Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark one)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2008
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number 0-16132
CELGENE CORPORATION
(Exact name of registrant as specified in its charter)
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Delaware
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22-2711928 |
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(State or other jurisdiction of incorporation
or organization)
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(I.R.S. Employer Identification
Number) |
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86 Morris Avenue, Summit, NJ
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07901 |
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(Address of principal executive offices)
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(Zip Code) |
(908) 673-9000
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
At October 23, 2008, 458,188,433 shares of Common Stock, par value $.01 per share, were
outstanding.
CELGENE CORPORATION
FORM 10-Q TABLE OF CONTENTS
2
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(Dollars in thousands, except per share amounts)
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Three-Month Periods Ended |
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Nine-Month Periods Ended |
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September 30, |
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September 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Revenue: |
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Net product sales |
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$ |
567,017 |
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$ |
331,169 |
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$ |
1,541,556 |
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$ |
919,910 |
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Collaborative agreements and other revenue |
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2,402 |
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4,616 |
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9,960 |
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14,520 |
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Royalty revenue |
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23,046 |
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14,123 |
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75,011 |
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56,800 |
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Total revenue |
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592,465 |
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349,908 |
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1,626,527 |
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991,230 |
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Expenses: |
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Cost of goods sold (excluding amortization
expense) |
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70,534 |
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34,066 |
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190,452 |
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84,840 |
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Research and development |
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160,911 |
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130,841 |
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462,650 |
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301,341 |
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Selling, general and administrative |
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168,607 |
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94,736 |
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485,345 |
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310,669 |
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Amortization of acquired intangible assets |
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32,833 |
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2,290 |
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77,842 |
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6,755 |
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Acquired in-process research and development |
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1,740,000 |
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Total expenses |
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432,885 |
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261,933 |
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2,956,289 |
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703,605 |
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Operating income (loss) |
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159,580 |
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87,975 |
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(1,329,762 |
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287,625 |
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Other income and expense: |
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Interest and investment income, net |
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19,678 |
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28,296 |
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69,281 |
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79,447 |
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Equity in losses of affiliated companies |
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2,338 |
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1,106 |
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8,761 |
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3,338 |
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Interest expense |
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512 |
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2,614 |
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3,968 |
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7,913 |
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Other income (expense), net |
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2,464 |
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732 |
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4,957 |
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(3,345 |
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Income (loss) before income taxes |
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178,872 |
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113,283 |
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(1,268,253 |
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352,476 |
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Income tax provision |
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42,058 |
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74,450 |
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116,138 |
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201,364 |
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Net income (loss) |
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$ |
136,814 |
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$ |
38,833 |
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$ |
(1,384,391 |
) |
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$ |
151,112 |
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Net income (loss) per common share: |
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Basic |
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$ |
0.30 |
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$ |
0.10 |
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$ |
(3.17 |
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$ |
0.40 |
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Diluted |
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$ |
0.29 |
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$ |
0.09 |
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$ |
(3.17 |
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$ |
0.36 |
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Weighted average shares: |
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Basic |
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456,509 |
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383,774 |
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437,206 |
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380,841 |
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Diluted |
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468,891 |
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432,817 |
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437,206 |
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431,208 |
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See accompanying Notes to Unaudited Consolidated Financial Statements
3
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(Dollars in thousands, except per share amounts)
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September 30, |
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December 31, |
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2008 |
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2007 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
1,517,120 |
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$ |
1,218,273 |
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Marketable securities available for sale |
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937,050 |
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1,520,645 |
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Accounts receivable, net of allowances of $7,927 and $4,213
at September 30, 2008 and December 31, 2007, respectively |
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275,409 |
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167,252 |
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Inventory |
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90,344 |
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49,076 |
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Deferred income taxes |
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59,808 |
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20,506 |
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Other current assets |
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144,483 |
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108,669 |
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Total current assets |
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3,024,214 |
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3,084,421 |
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Property, plant and equipment, net |
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234,414 |
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197,428 |
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Investment in affiliated companies |
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18,245 |
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14,422 |
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Intangible assets, net |
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462,235 |
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92,658 |
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Goodwill |
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523,617 |
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39,033 |
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Other assets |
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94,699 |
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183,322 |
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Total assets |
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$ |
4,357,424 |
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$ |
3,611,284 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
54,938 |
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$ |
37,876 |
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Accrued expenses |
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329,678 |
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159,220 |
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Income taxes payable |
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15,541 |
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4,989 |
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Convertible notes |
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196,555 |
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Current portion of deferred revenue |
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1,365 |
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7,666 |
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Other current liabilities |
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47,488 |
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26,625 |
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Total current liabilities |
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449,010 |
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432,931 |
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Deferred revenue, net of current portion |
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3,095 |
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60,303 |
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Non-current income taxes payable |
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257,068 |
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211,307 |
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Other non-current liabilities |
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59,890 |
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62,799 |
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Total liabilities |
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769,063 |
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767,340 |
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Commitments and Contingencies |
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Stockholders Equity: |
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Preferred stock, $.01 par value per share, 5,000,000 shares
authorized; none outstanding at September 30, 2008 and December 31, 2007, respectively |
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Common stock, $.01 par value per share, 575,000,000 shares authorized; issued
462,213,553 and 407,150,694 shares at September 30, 2008 and December 31, 2007, respectively |
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4,622 |
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4,072 |
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Common stock in treasury, at cost; 4,092,612 and 4,026,116 shares
at September 30, 2008 and December 31, 2007, respectively |
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(153,769 |
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(149,519 |
) |
Additional paid-in capital |
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5,035,170 |
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2,780,849 |
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(Accumulated deficit) retained earnings |
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(1,259,731 |
) |
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124,660 |
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Accumulated other comprehensive (loss) income |
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(37,931 |
) |
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83,882 |
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Total stockholders equity |
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3,588,361 |
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2,843,944 |
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Total liabilities and stockholders equity |
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$ |
4,357,424 |
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$ |
3,611,284 |
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See accompanying Notes to Unaudited Consolidated Financial Statements
4
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Dollars in thousands)
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Nine-Month Periods Ended |
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September 30, |
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2008 |
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2007 |
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Cash flows from operating activities: |
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Net (loss) income |
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$ |
(1,384,391 |
) |
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$ |
151,112 |
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Adjustments to reconcile net (loss) income to net cash
provided by operating activities: |
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Depreciation of long-term assets |
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25,470 |
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15,455 |
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Amortization of intangible assets |
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78,138 |
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|
7,047 |
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Provision for accounts receivable allowances |
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6,642 |
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6,353 |
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Deferred income taxes |
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(9,770 |
) |
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|
(4,334 |
) |
Acquired in-process research and development |
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1,740,000 |
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Share-based compensation expense |
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|
75,650 |
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|
41,630 |
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Equity in losses of affiliated companies |
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8,362 |
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2,910 |
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Share-based employee benefit plan expense |
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7,358 |
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|
6,436 |
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Other, net |
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12,434 |
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|
1,526 |
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Change in current assets and liabilities, excluding the effect of
acquisition: |
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Accounts receivable |
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(70,740 |
) |
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(23,148 |
) |
Inventory |
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(5,799 |
) |
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(34,480 |
) |
Other operating assets |
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(12,359 |
) |
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(11,088 |
) |
Accounts payable and other operating liabilities |
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(20,708 |
) |
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|
61,162 |
|
Income tax payable |
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|
26,088 |
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|
93,085 |
|
Deferred revenue |
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(31 |
) |
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(2,733 |
) |
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Net cash provided by operating activities |
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|
476,344 |
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|
310,933 |
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Cash flows from investing activities: |
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Proceeds from sales of marketable securities available for sale |
|
|
981,502 |
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|
1,462,836 |
|
Purchases of marketable securities available for sale |
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|
(471,699 |
) |
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|
(2,362,302 |
) |
Payments for acquisition of business, net of cash acquired |
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|
(746,779 |
) |
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Capital expenditures |
|
|
(53,635 |
) |
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|
(38,447 |
) |
Investment in affiliated companies |
|
|
(12,185 |
) |
|
|
(1,621 |
) |
Purchases of investment securities |
|
|
(8,236 |
) |
|
|
(23,356 |
) |
Other |
|
|
11,528 |
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|
Net cash used in investing activities |
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|
(299,504 |
) |
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|
(962,890 |
) |
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Cash flows from financing activities: |
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Net proceeds from exercise of common stock options and warrants |
|
|
106,932 |
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|
136,033 |
|
Excess tax benefit from share-based compensation arrangements |
|
|
59,459 |
|
|
|
112,614 |
|
|
|
|
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|
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Net cash provided by financing activities |
|
|
166,391 |
|
|
|
248,647 |
|
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|
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|
|
Effect of currency rate changes on cash and cash equivalents |
|
|
(44,384 |
) |
|
|
4,630 |
|
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|
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|
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|
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|
Net increase (decrease) in cash and cash equivalents |
|
$ |
298,847 |
|
|
$ |
(398,680 |
) |
|
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|
Cash and cash equivalents at beginning of period |
|
$ |
1,218,273 |
|
|
$ |
1,439,415 |
|
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Cash and cash equivalents at end of period |
|
$ |
1,517,120 |
|
|
$ |
1,040,735 |
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|
|
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|
|
|
|
See accompanying Notes to Unaudited Consolidated Financial Statements
5
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS (Continued)
(Unaudited)
(Dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Periods Ended |
|
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash investing and
financing activity: |
|
|
|
|
|
|
|
|
Change in net unrealized loss on marketable securities
available for sale and cash flow hedges |
|
$ |
100,527 |
|
|
$ |
43,988 |
|
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|
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|
|
|
|
|
Matured shares tendered in connection with stock
option exercises |
|
$ |
(4,250 |
) |
|
$ |
(6,457 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible notes |
|
$ |
196,543 |
|
|
$ |
130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
1,640 |
|
|
$ |
5,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes paid |
|
$ |
28,084 |
|
|
$ |
|
|
|
|
|
|
|
|
|
See accompanying Notes to Unaudited Consolidated Financial Statements
6
1. Nature of Business and Summary of Significant Accounting Policies
Nature of Business and Basis of Presentation: Celgene Corporation and its subsidiaries
(collectively Celgene or the Company) is a global biopharmaceutical company primarily engaged
in the discovery, development and commercialization of innovative therapies designed to treat
cancer and immune-inflammatory diseases. On March 7, 2008, the Company acquired all of the
outstanding common stock and stock options of Pharmion Corporation, or Pharmion, which prior to the
acquisition was a global biopharmaceutical company that acquired, developed and commercialized
innovative products for the treatment of hematology and oncology patients, for $2.67 billion in a
combination of cash and Celgene common stock. The Companys commercial stage products include
REVLIMID®, THALOMID® / Thalidomide, VIDAZA®, ALKERAN®
and FOCALIN®. FOCALIN® is sold exclusively to Novartis Pharma AG, or
Novartis. The Company also derives revenues from a licensing agreement with Novartis, which
entitles it to royalties on FOCALIN XR® and the entire RITALIN® family of
drugs, and sales of bio-therapeutic products and services through the Companys Cellular
Therapeutics subsidiary.
The accompanying unaudited consolidated financial statements have been prepared from the books and
records of the Company pursuant to U.S. generally accepted accounting principles for interim
information and the rules and regulations of the Securities and Exchange Commission for reporting
on Form 10-Q. Pursuant to such rules and regulations, certain information and footnote disclosures
normally included in complete annual financial statements have been condensed or omitted. The
consolidated financial statements include the accounts of Celgene Corporation and its subsidiaries.
All intercompany transactions and balances have been eliminated. Investments in limited
partnerships and interests in which the Company has an equity interest of 50% or less and does not
otherwise have a controlling financial interest are accounted for by either the equity or cost
method. Certain immaterial reclassifications have been made to the prior period consolidated
financial statements in order to conform to the current period presentation. The interim
consolidated financial statements should be read in conjunction with the consolidated financial
statements and notes thereto included in the Companys Annual Report on Form 10-K for the year
ended December 31, 2007.
The preparation of the consolidated financial statements requires management to make estimates and
assumptions that affect reported amounts and disclosures. Actual results could differ from those
estimates. The Company is subject to certain risks and uncertainties related to product
development, regulatory approval, market acceptance, scope of patent and proprietary rights,
intense competition, rapid technological change and product liability.
Interim results may not be indicative of the results that may be expected for the full year. In
the opinion of management, these financial statements include all normal and recurring adjustments
considered necessary for a fair presentation of these interim consolidated financial statements.
Recent Accounting Principles: In September 2006, the Financial Accounting Standards Board, or
FASB, issued Statement of Financial Accounting Standards, or SFAS, No. 157, Fair Value
Measurements, or SFAS 157, which establishes a framework for measuring fair value and expands
disclosures about fair value measurements. The FASB partially deferred the effective date of SFAS
157 for non-financial assets and liabilities that are recognized or disclosed at fair value in the
financial statements on a nonrecurring basis to fiscal years beginning after November 15, 2008.
The effective date for financial assets and liabilities that are recognized on a recurring basis
was January 1, 2008. The Company has determined that its adoption of SFAS 157 on January 1, 2008
for financial assets and liabilities did not have a material impact on its consolidated financial
statements. See Note 6 for expanded disclosures required by SFAS 157. The Company is currently
evaluating the impact that the adoption of SFAS 157 related to non-financial assets will have, if
any, on its consolidated financial statements.
7
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, or SFAS 159, which provides companies with an option to report selected
financial assets and liabilities at fair value. SFAS 159 establishes presentation and disclosure
requirements designed to facilitate comparisons between companies that choose different measurement
attributes for similar types of assets and liabilities and highlights the effect of a companys
choice to use fair value on its earnings. It also requires a company to display the fair value of
those assets and liabilities for which it has chosen to use fair value on the face of the balance
sheet. SFAS 159 was effective for the Company beginning January 1, 2008 and did not have a
material impact on its consolidated financial statements.
In June 2007, the FASB ratified Emerging Issues Task Force, or EITF, Issue No. 07-3, Accounting
for Non-Refundable Advance Payments for Goods or Services to be Used in Future Research and
Development Activities, or EITF 07-3, which provides that non-refundable advance payments for
future research and development activities should be deferred and capitalized until the related
goods are delivered or the related services are performed. EITF 07-3 was effective for the Company
on a prospective basis beginning January 1, 2008 and did not have a material impact on its
consolidated financial statements.
In December 2007, the FASB ratified EITF Issue No. 07-1, Accounting for Collaborative Arrangements
Related to the Development and Commercialization of Intellectual Property, or EITF 07-1, which
provides guidance on how the parties to a collaborative agreement should account for costs incurred
and revenue generated on sales to third parties, how sharing payments pursuant to a collaboration
agreement should be presented in the income statement and certain related disclosure requirements.
EITF 07-1 will be effective for the Company beginning January 1, 2009 on a retrospective basis.
The Company is currently evaluating the impact that the adoption of EITF 07-1 will have, if any, on
its consolidated financial statements.
In December 2007, the FASB issued SFAS No. 141R, Business Combinations, or SFAS 141R, which
replaces FASB Statement No. 141, Business Combinations, and requires an acquirer to recognize the
assets acquired, the liabilities assumed and any noncontrolling interest in the acquiree at the
acquisition date, measured at their fair values as of that date, with limited exceptions specified
in the Statement. It is effective prospectively to business combinations for which the acquisition
date is on or after the beginning of the first annual reporting period beginning on or after
December 15, 2008.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial
Statements, an Amendment of ARB No. 51, or SFAS 160, which changes the accounting for and
reporting of noncontrolling interests (formerly known as minority interests) in consolidated
financial statements. SFAS 160 is effective January 1, 2009. Upon implementation, prior periods
will be recast for the changes required by SFAS 160. The Company is currently evaluating the
impact that the adoption of SFAS 160 will have, if any, on its consolidated financial statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging
Activities, or SFAS 161, which is intended to improve financial reporting about derivative
instruments and hedging activities by requiring enhanced disclosures to enable investors to better
understand their effects on an entitys financial position, financial performance and cash flows.
It is effective for financial statements issued for fiscal years and interim periods beginning
after November 15, 2008, with early adoption encouraged. The Company is currently evaluating the
impact that the adoption of SFAS 161 will have, if any, on its consolidated financial statements.
In May 2008, the FASB issued FASB Staff Position, or FSP, No. APB 14-1, Accounting for Convertible
Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement),
or FSP APB 14-1, which requires separate accounting for the debt and equity components of
convertible debt issuances that have a cash settlement feature permitting settlement partially or
fully in cash upon conversion.
8
A component of such debt issuances representative of the approximate fair value of the conversion
feature at inception should be bifurcated and recorded to equity, with the resulting debt discount
amortized to interest expense in a manner that reflects the issuers nonconvertible, unsecured debt
borrowing rate. The requirements for separate accounting must be applied retrospectively to
previously issued convertible debt issuances as well as prospectively to newly issued convertible
debt issuances, negatively affecting both net income and earnings per share, in financial
statements issued for fiscal years beginning after December 15, 2008. Since the Companys past
convertible debt issuance did not include a cash settlement feature, it does not expect the
adoption of FSP APB 14-1 will have any impact on its consolidated financial statements.
In June 2008, the FASB issued FSP EITF No. 03-6-1, Determining Whether Instruments Granted in
Share-Based Payment Transactions Are Participating Securities, or FSP EITF 03-6-1. The FSP
addresses whether instruments granted in share-based payment transactions are participating
securities prior to vesting and therefore need to be included in the earnings allocation in
calculating earnings per share under the two-class method described in SFAS No. 128, Earnings per
Share. The FSP requires companies to treat unvested share-based payment awards that have
non-forfeitable rights to dividends or dividend equivalents as a separate class of securities in
calculating earnings per share. The FSP is effective for fiscal years beginning after
December 15, 2008; earlier application is not permitted. Since the Companys past share-based
payment awards did not include non-forfeitable rights to dividends or dividend equivalents, it does
not expect the adoption of FSP EITF 03-6-1 will have any impact on its consolidated financial
statements.
Significant Accounting Policies: The Companys significant accounting policies are described in
Note 1 of the Notes to the Consolidated Financial Statements included in its Annual Report on Form
10-K for the year ended December 31, 2007. In addition, the following additional significant
accounting policy is now applicable:
Derivatives and Hedging Activities: SFAS No. 133, Accounting for Derivative Instruments and
Hedging Activities, or SFAS 133, as amended, requires that all derivative instruments be
recognized on the balance sheet at their fair value. Changes in the fair value of derivative
instruments are recorded each period in current earnings or other comprehensive income (loss),
depending on whether a derivative instrument is designated as part of a hedging transaction and, if
it is, the type of hedging transaction. For a derivative to qualify as a hedge at inception and
throughout the hedged period, the Company formally documents the nature and relationships between
the hedging instruments and hedged item. The Company assesses, both at inception and on an
on-going basis, whether the derivative instruments that are used in cash flow hedging transactions
are highly effective in offsetting the changes in cash flows of hedged items. The Company assesses
hedge ineffectiveness on a quarterly basis and records the gain or loss related to the ineffective
portion of derivative instruments, if any, to current earnings. If the Company determines that a
forecasted transaction is no longer probable of occurring, it discontinues hedge accounting and any
related unrealized gain or loss on the derivative instrument is recognized in current earnings.
The Company uses derivative instruments, including those not designated as part of a hedging
transaction, to manage its exposure to movements in foreign exchange rates. The use of these
derivative instruments modifies the exposure of these risks with the intent to reduce the risk or
cost to the Company. The Company does not use derivative instruments for speculative trading
purposes and is not a party to leveraged derivatives.
2. Acquisition of Pharmion Corporation
On March 7, 2008, Celgene acquired all of the outstanding common stock and stock options of
Pharmion in a transaction accounted for under the purchase method of accounting for business
combinations. Under the purchase method of accounting, the assets acquired and liabilities assumed
of Pharmion are recorded as of the acquisition date, at their respective fair values, and
consolidated with those of Celgene. The reported consolidated financial condition and results of
operations of Celgene after completion of the acquisition
reflect these fair values. The operating results of Pharmion are included in the Companys
consolidated financial statements from the date of acquisition.
9
Celgene paid a total purchase price of $2.761 billion to acquire all of the outstanding Pharmion
common shares and stock options. Each Pharmion share of common stock (other than shares owned by
Celgene or its wholly owned subsidiaries, held in Pharmions treasury or to which appraisal rights
were perfected) were converted into the right to receive (i) 0.8367 shares of common stock of
Celgene and (ii) $25.00 in cash. The combination of cash and Celgene stock paid to Pharmion
stockholders consisted of $921.0 million in cash and approximately 30.8 million shares of Celgene
common stock valued at $1.749 billion. The purchase price included acquisition-related costs of
$26.2 million, the fair value of vested Celgene stock options issued of $44.9 million and the cost
of Celgenes investment in Pharmion common shares prior to the acquisition.
Prior to the acquisition, Pharmion was a global biopharmaceutical company that acquired, developed
and commercialized innovative products for the treatment of hematology and oncology patients.
Celgene acquired Pharmion to enhance its portfolio of therapies for patients with life-threatening
illnesses worldwide with the addition of Pharmions marketed products, and several products in
development for the treatment of hematological and solid tumor cancers. By combining this new
product portfolio with Celgenes existing operational and financial capabilities, Celgene expects
to enlarge its global market share through increased product offerings and expanded clinical,
regulatory and commercial capabilities.
|
|
|
|
|
(Amounts in thousands) |
|
|
|
|
Purchase Price Summary: |
|
|
|
|
|
|
|
|
|
Stock issued at fair value |
|
$ |
1,749,222 |
|
Cash paid |
|
|
920,805 |
|
Acquisition-related costs |
|
|
26,187 |
|
Fully vested stock options issued |
|
|
44,924 |
|
Pharmion shares previously owned |
|
|
20,212 |
|
|
|
|
|
Total purchase price paid |
|
$ |
2,761,350 |
|
|
|
|
|
The acquisition was accounted for using the purchase method of accounting for business combinations
and the preliminary purchase price allocation resulted in the following amounts being allocated to
the assets acquired and liabilities assumed at the acquisition date based upon their respective
fair values.
|
|
|
|
|
(Amounts in thousands) |
|
March 7, 2008 |
|
|
|
|
|
|
Current assets |
|
$ |
340,415 |
|
Property, plant and equipment |
|
|
8,404 |
|
Developed product rights |
|
|
510,986 |
|
In-process research and development |
|
|
1,740,000 |
|
Other noncurrent assets |
|
|
304 |
|
|
|
|
|
Assets acquired |
|
|
2,600,109 |
|
Restructuring |
|
|
(69,000 |
) |
Net deferred taxes |
|
|
(128,352 |
) |
Liabilities assumed |
|
|
(141,748 |
) |
|
|
|
|
Net assets acquired |
|
|
2,261,009 |
|
Goodwill |
|
|
500,341 |
|
|
|
|
|
Acquisition cost |
|
$ |
2,761,350 |
|
|
|
|
|
10
The fair value of the acquired identifiable intangible assets consists primarily of developed
product rights for the following marketed products at date of acquisition: VIDAZA® IV
in the U.S. market, Thalidomide Pharmion in certain foreign markets and other minor commercialized
products. The weighted average amortization period for these assets, in total, is 6.5 years. The
weighted average amortization period for compassionate use rights is 1.2 years, while the weighted
average amortization period for the developed product rights is 7.1 years.
In-process research and development, or IPR&D, represents compounds under development by Pharmion
at the date of acquisition that had not yet achieved regulatory approval for marketing in certain
markets or had not yet been completed and have no alternative future use. The $1.74 billion
estimated fair value of these intangibles was derived using the multi-period excess-earnings
method, a form of the income approach. The IPR&D primarily related to development and approval
initiatives for VIDAZA® IV in the E.U. market, the oral form of azacitidine in the U.S.
and E.U. markets and Thalidomide Pharmion® in the E.U. market. The projected cash flows
for valuation purposes were based on key assumptions such as estimates of revenues and operating
profits related to the programs considering their stages of development; the time and resources
needed to complete the regulatory approval process for the products; and the life of the potential
commercialized products and associated risks, including the inherent difficulties and uncertainties
in obtaining regulatory approvals.
For VIDAZA® IV in the E.U. market, the related future net cash flows were estimated
using a risk-adjusted discount rate of 10.0% and an anticipated regulatory approval date in late
2008 with market exclusivity rights expected to continue through 2019. For the oral form of
azacitidine in the United States and European Union, the future net cash flows were estimated using
a risk-adjusted discount rate of 11.0% for each market. The anticipated regulatory approval in the
European Union was assumed for 2013 with exclusivity continuing through 2023, and the anticipated
regulatory approval in the United States was assumed for 2013 with exclusivity continuing through
2018. For Thalidomide Pharmion® in the E.U. market, the future net cash flows were
estimated using a risk-adjusted discount rate of 9.5% and an anticipated regulatory approval date
in 2008 with exclusivity continuing through 2018.
In accordance with FASB Interpretation No. 4, Applicability of FASB Statement No. 2 to Business
Combinations Accounted for by the Purchase Method, the purchase price allocated to IPR&D
intangible assets has been expensed to income immediately subsequent to the acquisition because the
compounds do not have any alternative future use. This charge is not deductible for tax purposes.
The excess of purchase price over the fair value amounts assigned to the assets acquired and
liabilities assumed represents the goodwill amount resulting from the acquisition. The amount
allocated to goodwill is preliminary and subject to change, depending on the results of the final
purchase price allocation. The Company does not expect any portion of this goodwill to be
deductible for tax purposes. The goodwill attributable to the Companys acquisition of Pharmion
has been recorded as a noncurrent asset in the Companys Consolidated Balance Sheet and will not be
amortized, but is subject to review for impairment in accordance with SFAS No. 142, Goodwill and
Other Intangible Assets.
The allocation of the purchase price is subject to finalization of Celgenes management analysis of
the fair value of the assets acquired and liabilities assumed of Pharmion as of the acquisition
date. The final allocation of the purchase price may result in additional adjustments to the
recorded amounts of assets and liabilities, including goodwill, deferred taxes, accruals for
restructuring activities (see Note 3 below) and other tax liabilities, which may also result in
adjustments to depreciation and amortization charges. Celgenes management is continuing to
evaluate the purchase price allocation, including acquired uncertain tax positions, and expects the
final allocation to be completed during the fourth quarter ending December 31, 2008. Some of the
acquired uncertain tax positions are complex and can be significant, but at this time there is not
sufficient information to conclude on this matter.
11
Prior to the acquisition, Celgene had licensed exclusive rights relating to the development and
commercial use for thalidomide and its distribution system to Pharmion, and also maintained a
thalidomide supply agreement with Pharmion. The Company accounted for these arrangements in
accordance with EITF Issue No. 04-1, Accounting for Preexisting Relationships between the Parties
to a Business Combination. In addition, the Company has valued the reacquired thalidomide-related
rights in the valuation of developed product rights described above. Any assets and liabilities
that existed between Celgene and Pharmion as of the acquisition date have been eliminated in the
accompanying unaudited consolidated financial statements.
The following table provides unaudited pro forma financial information for the three- and
nine-month periods ended September 30, 2008 and 2007 as if the acquisition had occurred as of the
beginning of each year presented. For each year presented, the unaudited pro forma results include
the nonrecurring charge for IPR&D, amortization of acquired intangible assets, elimination of
expense and income related to pre-acquisition agreements with Pharmion, reduced interest and
investment income attributable to cash paid for the acquisition and the amortization of the
inventory step-up to fair value of acquired Pharmion product inventories. The unaudited pro forma
results do not reflect any operating efficiencies or potential cost savings that may result from
the combined operations of Celgene and Pharmion. Accordingly, these unaudited pro forma results
are presented for illustrative purposes and are not intended to represent or be indicative of the
actual results of operations of the combined company that would have been achieved had the
acquisition occurred at the beginning of each period presented, nor are they intended to represent
or be indicative of future results of operations.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Nine-Month Periods Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(Amounts in thousands, except per share) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
592,465 |
|
|
$ |
411,701 |
|
|
$ |
1,678,880 |
|
|
$ |
1,169,833 |
|
Net income (loss) |
|
$ |
136,814 |
|
|
$ |
(12,117 |
) |
|
$ |
(1,393,846 |
) |
|
$ |
(1,735,031 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.30 |
|
|
$ |
(0.03 |
) |
|
$ |
(3.19 |
) |
|
$ |
(4.23 |
) |
Diluted |
|
$ |
0.29 |
|
|
$ |
(0.03 |
) |
|
$ |
(3.19 |
) |
|
$ |
(4.23 |
) |
3. Restructuring
The acquisition cost of Pharmion includes liabilities related primarily to the planned exit of
certain business activities, involuntary terminations and the relocation of certain Pharmion
employees. The cost of these restructuring activities is estimated to be approximately $69.0
million, which includes employee severance costs of $16.8 million, early lease and contract
termination costs of $45.0 million, facility closing costs of $3.8 million and various other costs
of approximately $3.4 million primarily associated with exiting certain business activities of
Pharmion. The Company expects that all actions will be substantially completed within one year of
the effective date of the acquisition.
Payments related to the restructuring charge were $13,788 and $25,376 for the three- and nine-month
periods ended September 30, 2008, respectively.
12
The following table summarizes the changes to the restructuring reserves established as part of the
Pharmion acquisition on March 7, 2008 for the nine-month period ended September 30, 2008.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance |
|
|
|
|
|
|
Balance |
|
(Amounts in thousands) |
|
March 7, 2008 |
|
|
Payments |
|
|
Septmeber 30, 2008 |
|
|
Severance costs |
|
$ |
16,800 |
|
|
$ |
(13,753 |
) |
|
$ |
3,047 |
|
Contract termination fees |
|
|
45,000 |
|
|
|
(6,758 |
) |
|
|
38,242 |
|
Facility closing costs |
|
|
3,800 |
|
|
|
(2,931 |
) |
|
|
869 |
|
Other |
|
|
3,400 |
|
|
|
(1,934 |
) |
|
|
1,466 |
|
|
|
|
|
|
|
|
|
|
|
Total restructuring costs |
|
$ |
69,000 |
|
|
$ |
(25,376 |
) |
|
$ |
43,624 |
|
|
|
|
|
|
|
|
|
|
|
4. Earnings Per Share (EPS)
Basic earnings per share is computed by dividing net income by the weighted-average number of
common shares outstanding during the period. Diluted earnings per share is computed by dividing
net income adjusted to add back the after-tax amount of interest recognized in the period
associated with any convertible debt issuance that may be dilutive by the weighted-average number
of common shares outstanding during the period increased to include all additional common shares
that would have been outstanding as if the outstanding convertible debt was converted into shares
of common stock and assuming potentially dilutive common shares, resulting from option exercises,
had been issued and any proceeds thereof used to repurchase common stock at the average market
price during the period. The assumed proceeds used to repurchase common stock are the sum of the
amount to be paid to the Company upon exercise of options, the amount of compensation cost
attributed to future services and not yet recognized and, if applicable, the amount of excess
income tax benefit that would be credited to paid-in capital upon exercise.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Nine-Month Periods Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(Amounts in thousands except per share) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
Net income (loss) |
|
$ |
136,814 |
|
|
$ |
38,833 |
|
|
$ |
(1,384,391 |
) |
|
$ |
151,112 |
|
Interest expense on convertible debt, net of tax |
|
|
|
|
|
|
1,392 |
|
|
|
|
|
|
|
4,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) for diluted computation |
|
$ |
136,814 |
|
|
$ |
40,225 |
|
|
$ |
(1,384,391 |
) |
|
$ |
155,289 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
456,509 |
|
|
|
383,774 |
|
|
|
437,206 |
|
|
|
380,841 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options, warrants and other incentives |
|
|
12,382 |
|
|
|
16,042 |
|
|
|
|
|
|
|
17,366 |
|
Convertible debt |
|
|
|
|
|
|
33,001 |
|
|
|
|
|
|
|
33,001 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
468,891 |
|
|
|
432,817 |
|
|
|
437,206 |
|
|
|
431,208 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.30 |
|
|
$ |
0.10 |
|
|
$ |
(3.17 |
) |
|
$ |
0.40 |
|
Diluted |
|
$ |
0.29 |
|
|
$ |
0.09 |
|
|
$ |
(3.17 |
) |
|
$ |
0.36 |
|
The total number of potential common shares excluded from the diluted earnings per share
computation because their inclusion would have been anti-dilutive was 9,392,013 and 4,855,003
shares for the three-month periods ended September 30, 2008 and 2007, respectively. The total
number of potential common shares excluded from the computation for the nine-month periods ended
September 30, 2008 and 2007 was 33,014,354 and 5,464,407, respectively. All of the potentially
dilutive securities for the nine-month period ended September 30, 2008 were determined to be
anti-dilutive due to the net loss reported. Substantially all of the convertible debt was
converted into shares of common stock by its maturity date of June 1, 2008, with the balance paid
in cash.
13
5. Comprehensive Income (Loss)
The components of comprehensive income (loss) consist of net income (loss), the after-tax effects
of changes in net unrealized gains (losses) on marketable securities classified as available for
sale, net unrealized gains and (losses) related to cash flow hedges and changes in currency
translation adjustments. A summary of comprehensive income (loss) for the three- and nine-month
periods ended September 30, 2008 and 2007 follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Nine-Month Periods Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
136,814 |
|
|
$ |
38,833 |
|
|
$ |
(1,384,391 |
) |
|
$ |
151,112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive (loss) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized (losses) gains on marketable
securities available for sale, net of tax |
|
|
(4,052 |
) |
|
|
24,981 |
|
|
|
(3,947 |
) |
|
|
24,278 |
|
Reversal of unrealized gains on Pharmion
investment, net of tax |
|
|
|
|
|
|
|
|
|
|
(62,806 |
) |
|
|
|
|
Reclassification adjustment for losses
included in net income (loss) |
|
|
3,515 |
|
|
|
2,639 |
|
|
|
1,275 |
|
|
|
4,085 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive (losses) gains related to
marketable securities available for sale, net
of tax |
|
|
(537 |
) |
|
|
27,620 |
|
|
|
(65,478 |
) |
|
|
28,363 |
|
Net unrealized gains related to cash flow
hedges, net of tax |
|
|
6,786 |
|
|
|
|
|
|
|
6,786 |
|
|
|
|
|
Currency translation adjustments |
|
|
(91,299 |
) |
|
|
9,908 |
|
|
|
(63,120 |
) |
|
|
15,803 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive (loss) income |
|
|
(85,050 |
) |
|
|
37,528 |
|
|
|
(121,812 |
) |
|
|
44,166 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) |
|
$ |
51,764 |
|
|
$ |
76,361 |
|
|
$ |
(1,506,203 |
) |
|
$ |
195,278 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
6. Financial Instruments and Fair Value Measurement
The table below presents information about assets and liabilities that are measured at fair value
on a recurring basis as of September 30, 2008 and the valuation techniques the Company utilized to
determine such fair value. In general, fair values determined based on Level 1 inputs utilize
quoted prices (unadjusted) in active markets for identical assets or liabilities. The Companys
Level 1 assets consist of marketable equity securities. Fair values determined based on Level 2
inputs utilize observable quoted prices for similar assets and liabilities in active markets and
observable quoted prices from identical or similar assets in markets that are not very active. The
Companys Level 2 assets consist of mortgage-backed obligations, U.S. Treasury securities, U.S.
government-sponsored agency securities, corporate debt securities, forward currency contracts and
warrants to purchase equity securities. Fair values determined based on Level 3 inputs utilize
unobservable inputs and include valuations of assets or liabilities for which there is little, if
any, market activity. The Companys Level 3 assets consist of a private cash fund with a carrying
value calculated pursuant to the amortized cost method, which values each investment at its
acquisition cost as adjusted for amortization of premium or accumulation of discount over the
investments remaining life, net of impairment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Price in |
|
|
Significant |
|
|
Significant |
|
|
|
|
|
|
|
Active Markets for |
|
|
Other Observable |
|
|
Unobservable |
|
|
|
Balance at |
|
|
Identical Assets |
|
|
Inputs |
|
|
Inputs |
|
(Amounts in thousands) |
|
September 30, 2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
$ |
69,027 |
|
|
$ |
|
|
|
$ |
69,027 |
|
|
$ |
|
|
Available-for-sale
securities |
|
|
937,050 |
|
|
|
661 |
|
|
|
921,788 |
|
|
|
14,601 |
|
Forward currency
contracts |
|
|
(3,379 |
) |
|
|
|
|
|
|
(3,379 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,002,698 |
|
|
$ |
661 |
|
|
$ |
987,436 |
|
|
$ |
14,601 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table is a roll-forward of the fair value of the private cash fund, determined by
Level 3 inputs:
|
|
|
|
|
|
|
Fair Value |
|
|
|
Measurements |
|
|
|
Using Significant |
|
(Amounts in thousands) |
|
Unobservable Inputs |
|
|
|
|
|
|
Balance at December 31, 2007 |
|
$ |
37,038 |
|
Total gains or losses (realized and unrealized) |
|
|
|
|
Settlements |
|
|
(22,437 |
) |
Transfers in and/or out of Level 3 |
|
|
|
|
|
|
|
|
Balance at September 30, 2008 |
|
$ |
14,601 |
|
|
|
|
|
Foreign Currency Forward Contracts: The Company uses foreign currency forward contracts to hedge
specific forecasted intercompany transactions denominated in foreign currencies and to reduce
exposures to foreign currency fluctuations of certain assets and liabilities denominated in foreign
currencies.
The Company enters into foreign currency forward contracts to protect against possible changes in
values of certain anticipated foreign currency cash flows resulting from changes in foreign
currency exchange rates, primarily associated with U.S. dollar denominated expenses incurred by
subsidiaries in Europe. These foreign currency forward contracts are designated as cash flow
hedges and accordingly, to the extent effective, any unrealized gains or losses on them are
reported in other comprehensive income (loss) and reclassified to earnings in the same periods
during which the underlying hedged transactions affect earnings. Any ineffectiveness on these
foreign currency forward contracts is reported in other income (expense), net.
The foreign currency forward hedging contracts outstanding at September 30, 2008 had an aggregate
notional amount of approximately $75.7 million and had settlement dates within twelve months. The
fair value of these contracts was $8.4 million and was included in other current assets at
September 30, 2008, including gains, net of tax, of $6.8 million included in other comprehensive
income (loss).
Hedge ineffectiveness for the three- and nine-month periods ended September 30, 2008 and 2007 was
insignificant. Time value excluded from the hedge effectiveness assessment for the three- and
nine-month periods ended September 30, 2008 was $0.9 million as compared to zero for the three- and
nine-month periods ended September 30, 2007 and was included in other income (expense), net.
The Company also enters into foreign currency forward contracts to reduce exposures to foreign
currency fluctuations of certain assets and liabilities denominated in foreign currencies. These
foreign currency forward contracts have not been designated as hedges and, accordingly, any changes
in their fair value are recognized in other income (expense), net in the current period. The
aggregate notional amount of the foreign currency forward non-designated hedging contracts
outstanding at September 30, 2008 was approximately $366.9 million. The fair value of these
contracts was $11.7 million and was included in accrued expenses at September 30, 2008.
15
7. Cash, Cash Equivalents and Marketable Securities Available for Sale
Money market funds and marketable securities classified as cash equivalents of $1.270 billion and
$1.006 billion at September 30, 2008 and December 31, 2007, respectively, were recorded at cost,
which approximates fair value and are included in cash and cash equivalents. The amortized cost,
gross unrealized holding gains, gross unrealized holding losses and estimated fair value of
available-for-sale securities by major security type and class of security at September 30, 2008
and December 31, 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
(Amounts in thousands) |
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
September 30, 2008 |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mortgage-backed obligations |
|
$ |
174,052 |
|
|
$ |
2,090 |
|
|
$ |
(230 |
) |
|
$ |
175,912 |
|
U.S. Treasury securities |
|
|
176,250 |
|
|
|
2,839 |
|
|
|
(223 |
) |
|
|
178,866 |
|
U.S. government-sponsored
agency securities |
|
|
563,127 |
|
|
|
4,397 |
|
|
|
(514 |
) |
|
|
567,010 |
|
Private cash fund shares |
|
|
14,601 |
|
|
|
|
|
|
|
|
|
|
|
14,601 |
|
Marketable equity securities |
|
|
661 |
|
|
|
|
|
|
|
|
|
|
|
661 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale
marketable securities |
|
$ |
928,691 |
|
|
$ |
9,326 |
|
|
$ |
(967 |
) |
|
$ |
937,050 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
(Amounts in thousands) |
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
December 31, 2007 |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mortgage-backed obligations |
|
$ |
216,255 |
|
|
$ |
2,253 |
|
|
$ |
(108 |
) |
|
$ |
218,400 |
|
U.S. Treasury securities |
|
|
150,175 |
|
|
|
1,410 |
|
|
|
(28 |
) |
|
|
151,557 |
|
U.S. government-sponsored agency securities |
|
|
969,312 |
|
|
|
10,690 |
|
|
|
(131 |
) |
|
|
979,871 |
|
Corporate debt securities |
|
|
13,448 |
|
|
|
19 |
|
|
|
(1,611 |
) |
|
|
11,856 |
|
Private cash fund shares |
|
|
37,038 |
|
|
|
|
|
|
|
|
|
|
|
37,038 |
|
Marketable equity securities |
|
|
20,212 |
|
|
|
101,711 |
|
|
|
|
|
|
|
121,923 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale marketable securities |
|
$ |
1,406,440 |
|
|
$ |
116,083 |
|
|
$ |
(1,878 |
) |
|
$ |
1,520,645 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mortgage-backed obligations include fixed rate asset-backed securities issued by the Federal
National Mortgage Association, the Federal Home Loan Mortgage Corporation and the Government
National Mortgage Association. U.S. government-sponsored agency securities include general
unsecured obligations of the issuing agency. Private cash fund shares are investments in enhanced
cash commingled funds. Marketable equity securities at December 31, 2007 consisted of the
Companys investment in the common shares of Pharmion, which were subsequently eliminated with the
acquisition of Pharmion in March 2008. Net unrealized gains in mortgage-backed obligations, U.S.
Treasury securities and U.S. government-sponsored agency securities primarily reflect the impact of
decreased interest rates at September 30, 2008 and December 31, 2007. Unrealized losses related to
corporate debt securities at December 31, 2007 were primarily due to widening credit spreads.
16
Duration of debt securities classified as available-for-sale at September 30, 2008 was as follows:
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Fair |
|
(Amounts in thousands) |
|
Cost |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
Duration of one year or less |
|
$ |
363,348 |
|
|
$ |
365,813 |
|
Duration of one through three years |
|
|
467,899 |
|
|
|
472,681 |
|
Duration of three through five years |
|
|
76,962 |
|
|
|
77,463 |
|
Duration of five years or more |
|
|
19,821 |
|
|
|
20,432 |
|
|
|
|
|
|
|
|
Total |
|
$ |
928,030 |
|
|
$ |
936,389 |
|
|
|
|
|
|
|
|
8. Inventory
A summary of inventories by major category at September 30, 2008 and December 31, 2007 follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Raw materials |
|
$ |
16,028 |
|
|
$ |
8,899 |
|
Work in process |
|
|
25,371 |
|
|
|
21,214 |
|
Finished goods |
|
|
48,945 |
|
|
|
18,963 |
|
|
|
|
|
|
|
|
Total |
|
$ |
90,344 |
|
|
$ |
49,076 |
|
|
|
|
|
|
|
|
Inventory at September 30, 2008 increased $41.3 million compared to December 31, 2007 primarily as
a result of the Pharmion acquisition in addition to an increase in the inventory levels of all
other products.
17
9. Investment in Affiliated Companies
A summary of the Companys equity investment in affiliated companies follows:
|
|
|
|
|
|
|
|
|
(Amounts in thousands) |
|
September 30, |
|
|
December 31, |
|
Investment in Affiliated Companies |
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Investment in affiliated companies (1) |
|
$ |
14,410 |
|
|
$ |
2,191 |
|
Excess of investment over share of equity (2) |
|
|
3,835 |
|
|
|
12,231 |
|
|
|
|
|
|
|
|
Investment in affiliated companies |
|
$ |
18,245 |
|
|
$ |
14,422 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Nine-Month Periods Ended |
|
(Amounts in thousands) |
|
September 30, |
|
|
September 30, |
|
Equity in Losses of Affiliated Companies |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Affiliated companies losses (1) |
|
$ |
2,338 |
|
|
$ |
1,031 |
|
|
$ |
8,761 |
|
|
$ |
3,112 |
|
Amortization of intangibles |
|
|
|
|
|
|
75 |
|
|
|
|
|
|
|
226 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in losses of affiliated companies |
|
$ |
2,338 |
|
|
$ |
1,106 |
|
|
$ |
8,761 |
|
|
$ |
3,338 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The Company records its interest and share of losses based on its ownership percentage. |
|
(2) |
|
Consists of goodwill at September 30, 2008 and December 31, 2007. |
The investment in affiliated companies includes additional equity investments totaling $12.2
million for the nine-month period ended September 30, 2008. The three- and nine-month periods
ended September 30, 2008 included other-than-temporary impairment losses of $1.6 million and $6.0
million, respectively. These impairment losses were based on an evaluation of several factors,
including a decrease in fair value of the equity investment below its cost.
10. Convertible Debt
In June 2003, the Company issued an aggregate principal amount of $400.0 million of unsecured
convertible notes due June 2008, referred to herein as the convertible notes. The convertible
notes had a five-year term and a coupon rate of 1.75% payable semi-annually on June 1 and December
1. Each $1,000 principal amount of convertible notes was convertible into 82.5592 shares of common
stock as adjusted, or a conversion price of $12.1125 per share, which represented a 50% premium to
the closing price on May 28, 2003 of the Companys common stock of $8.075 per share, after
adjusting prices for the two-for-one stock splits effected on February 17, 2006 and October 22,
2004. As of their maturity date, June 1, 2008, pursuant to the terms of the indenture, as amended,
governing the convertible notes, substantially all of the convertible notes were converted into an
aggregate 33,022,740 shares of common stock at the conversion price, with the balance paid in cash.
18
11. Intangible Assets and Goodwill
Intangible Assets: A summary of intangible assets by category follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Intangible |
|
|
Weighted |
|
(Amounts in thousands) |
|
Carrying |
|
|
Accumulated |
|
|
Assets, |
|
|
Average |
|
September 30, 2008 |
|
Value |
|
|
Amortization |
|
|
Net |
|
|
Life (Years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired developed product rights |
|
$ |
534,593 |
|
|
$ |
(76,205 |
) |
|
$ |
458,388 |
|
|
|
6.5 |
|
License |
|
|
4,250 |
|
|
|
(845 |
) |
|
|
3,405 |
|
|
|
13.8 |
|
Technology |
|
|
292 |
|
|
|
(53 |
) |
|
|
239 |
|
|
|
12.6 |
|
Acquired workforce |
|
|
321 |
|
|
|
(118 |
) |
|
|
203 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
539,456 |
|
|
$ |
(77,221 |
) |
|
$ |
462,235 |
|
|
|
6.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Intangible |
|
|
Weighted |
|
(Amounts in thousands) |
|
Carrying |
|
|
Accumulated |
|
|
Assets, |
|
|
Average |
|
December 31, 2007 |
|
Value |
|
|
Amortization |
|
|
Net |
|
|
Life (Years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Penn T supply agreements |
|
$ |
109,982 |
|
|
$ |
(21,470 |
) |
|
$ |
88,512 |
|
|
|
12.9 |
|
License |
|
|
4,250 |
|
|
|
(614 |
) |
|
|
3,636 |
|
|
|
13.8 |
|
Technology |
|
|
297 |
|
|
|
(36 |
) |
|
|
261 |
|
|
|
12.6 |
|
Acquired workforce |
|
|
318 |
|
|
|
(69 |
) |
|
|
249 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
114,847 |
|
|
$ |
(22,189 |
) |
|
$ |
92,658 |
|
|
|
12.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The gross carrying value of intangibles increased by $424.6 million from December 31, 2007 to
September 30, 2008, primarily due to the fair value assigned to pharmaceutical product rights
obtained as part of the Pharmion acquisition in March 2008. An immaterial amount of decrease in
gross carrying value of intangibles was due to changes in foreign exchange rates.
Amortization of intangible assets was $32.9 million and $2.4 million for the three-month periods
ended September 30, 2008 and 2007, respectively. Amortization for the nine-month periods ended
September 30, 2008 and 2007 was $78.1 million and $7.1 million, respectively. The increase in
amortization expense was due to amortization of the intangible assets resulting from the Pharmion
acquisition. Assuming no changes in the gross carrying amount of intangible assets, the
amortization of intangible assets for the next five years is estimated to be approximately $101.8
million for the year ending December 31, 2008, approximately $84.8 million for the year ending
December 31, 2009 and approximately $64.4 million for each of the years ending December 31, 2010
through 2012.
19
Goodwill: At September 30, 2008, the Companys goodwill related to the March 7, 2008 acquisition
of Pharmion and the October 21, 2004 acquisition of Penn T Limited. The final allocation of the
Pharmion purchase price may result in an adjustment to the recorded amount of goodwill and is
expected to be completed during the fourth quarter ending December 31, 2008. The change in
carrying value of goodwill is summarized as follows:
|
|
|
|
|
(Amounts in thousands) |
|
|
|
|
Balance, December 31, 2007 |
|
$ |
39,033 |
|
Acquisition of Pharmion |
|
|
500,341 |
|
Tax benefit on the exercise of Pharmion converted stock options |
|
|
(11,528 |
) |
Translation |
|
|
(4,229 |
) |
|
|
|
|
Balance, September 30, 2008 |
|
$ |
523,617 |
|
|
|
|
|
12. Share-Based Compensation
On June 18, 2008, the Companys stockholders approved an amendment and restatement of the 1998
Incentive Plan, or the Plan, which included the following key modifications: adoption of an
aggregate share reserve of 52,372,191 shares of Common Stock (which number reflects 11,844,865
shares of Common Stock expiring under the Plan and 10,155,135 new shares of Common Stock, plus
30,372,191 shares underlying outstanding awards previously granted under the Plan as of March 19,
2008); extension of the term of the Plan through April 16, 2018; addition of the authority to grant
other stock-based awards, including restricted stock units, under the Plan; and renaming the Plan
as the 2008 Stock Incentive Plan.
The following table summarizes the components of share-based compensation expense in the
consolidated statements of operations for the three- and nine-month periods ended September 30,
2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Nine-Month Periods Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of good sold |
|
$ |
668 |
|
|
$ |
582 |
|
|
$ |
1,829 |
|
|
$ |
1,378 |
|
Research and development |
|
|
10,964 |
|
|
|
5,220 |
|
|
|
32,264 |
|
|
|
11,165 |
|
Selling, general and administrative |
|
|
16,596 |
|
|
|
9,274 |
|
|
|
41,557 |
|
|
|
24,281 |
|
Other expense, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,806 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
28,228 |
|
|
$ |
15,076 |
|
|
$ |
75,650 |
|
|
$ |
41,630 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation cost included in inventory was $0.7 million at September 30, 2008 and $0.4
million at December 31, 2007.
As of September 30, 2008, there was $255.7 million of unrecognized compensation expense related to
the Companys various stock-based plans. These costs will be recognized over an expected remaining
weighted-average period of 2.5 years.
The weighted-average grant date fair value of the stock options issued during the three-month
periods ended September 30, 2008 and 2007 was $27.89 per share and $23.55 per share, respectively.
The weighted-average grant date fair value of the stock options issued during the nine-month
periods ended September 30, 2008 and 2007 was $25.71 per share and $23.09 per share, respectively.
There have been no significant changes to the assumptions used to estimate the fair value of
options granted during the nine-month period ended September 30, 2008, as compared to those
disclosed for the year ended December 31, 2007 in Note 13 to the Consolidated Financial Statements
included in the Companys Annual Report on Form 10-K.
20
Stock option transactions for the nine-month period ended September 30, 2008 under all plans are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
|
|
|
|
Price |
|
|
Contractual |
|
|
Value |
|
|
|
Options |
|
|
Per Option |
|
|
Term (Years) |
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2007 |
|
|
32,717,434 |
|
|
$ |
28.03 |
|
|
|
6.1 |
|
|
$ |
702,341 |
|
Changes during the period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
7,007,758 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued Pharmion acquisition |
|
|
1,206,031 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(7,904,283 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(468,074 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Expired |
|
|
(47,239 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2008 |
|
|
32,511,627 |
|
|
$ |
38.09 |
|
|
|
6.5 |
|
|
$ |
856,677 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at September 30, 2008 or
expected
to vest in the future |
|
|
31,995,063 |
|
|
$ |
37.70 |
|
|
|
6.4 |
|
|
$ |
854,330 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at September 30, 2008 |
|
|
18,595,201 |
|
|
$ |
23.84 |
|
|
|
4.7 |
|
|
$ |
733,840 |
|
The total fair value of shares vested during the nine-month periods ended September 30, 2008 and
2007 was $21.3 million and $26.4 million, respectively. The total intrinsic value of stock options
exercised during the nine-month periods ended September 30, 2008 and 2007 was $390.3 million and
$435.4 million, respectively. The Company primarily utilizes newly issued shares to satisfy the
exercise of stock options.
13. Income Taxes
The Company periodically evaluates the likelihood of the realization of deferred tax assets, and
reduces the carrying amount of those deferred tax assets, by a valuation allowance to the extent it
believes a portion will not be realized. The Company considers many factors when assessing the
likelihood of future realization of its deferred tax assets, including recent cumulative earnings
experience by taxing jurisdiction, expectations of future taxable income, the carryforward periods
available to it for tax reporting purposes and other relevant factors. Significant judgment is
required in making this assessment.
The Companys tax returns have been audited by the Internal Revenue Service, or IRS, through the
year ended December 31, 2003. Tax returns for the years ended December 31, 2004 and 2005 are
currently under examination by the IRS. The Company is also subject to audits by various state and
foreign taxing authorities, including, but not limited to, most U.S. states, major European and
Asian countries.
The Company regularly reevaluates its tax positions and the associated interest and penalties, if
applicable, resulting from audits of federal, state and foreign income tax filings, as well as
changes in tax law that would reduce or increase the technical merits of the position to below or
above more likely than not. The Company believes that its accruals for tax liabilities are
adequate for all open years. Many factors are considered in making these evaluations, including
past history, recent interpretations of tax law and the specifics of each matter. Because tax
regulations are subject to interpretation and tax litigation is inherently uncertain, these
evaluations can involve a series of complex judgments about future events and can rely heavily on
estimates and assumptions. These evaluations are based on estimates and assumptions that have been
deemed reasonable by management. However, if managements estimates are not representative of
actual outcomes, the Companys results of operations could be materially impacted.
21
Unrecognized tax benefits, represented by liabilities on the balance sheet and subject to audit,
arise when the estimated benefit recorded in the financial statements differs from the amounts
taken or expected to be taken in a tax return because of the uncertainties described above. These
unrecognized tax benefits relate primarily to issues common among multinational corporations.
Virtually all of these unrecognized tax benefits, if recognized, would impact the effective income
tax rate. The Company accounts for interest and penalties related to uncertain tax positions as
part of its provision for income taxes. Changes to the amount of unrecognized tax benefits from
January 1, 2008 relate primarily to current year operations. There are no unrecognized tax
benefits as of September 30, 2008 for which it is reasonably possible that there will be a
significant change in the next 12 months. The liability for unrecognized tax benefits is expected
to increase in the next 12 months relating to operations occurring in that period.
During the nine-month period ended September 30, 2008, the Companys effective tax rate was
negatively impacted by non-deductible in-process research and development charges incurred in
connection with the acquisition of Pharmion.
During the nine-month period ended September 30, 2007, the Company recorded a deferred tax benefit
of approximately $7.0 million, as a result of a research and experimentation tax credit study
covering prior years. In addition, the Company generated research and experimentation tax credits
of $18.1 million related to stock option compensation for which no deferred tax benefit was
recorded at September 30, 2007. Under SFAS No. 123R, Share-Based Payment, or SFAS 123R, excess
tax benefits related to stock option compensation are recognized in the period in which such
benefits are realized through the reduction of income taxes payable. These tax benefits will be
recorded as an increase in additional paid-in capital when realized. Also, during the nine-month
period ended September 30, 2007, the Company recorded a deferred tax expense of approximately $4.0
million to adjust deferred tax assets and liabilities for the effect of changes in state and
foreign tax rates.
14. Commitments and contingencies
The Company has entered into certain research and development collaboration arrangements with third
parties that include the funding of certain development, manufacturing and commercialization
efforts with the potential for future milestone and royalty payments upon the achievement of
pre-established developmental, regulatory, and /or commercial targets. The Companys obligation to
fund these efforts is contingent upon continued involvement in the programs and/or the lack of any
adverse events which could cause the discontinuance of the programs. Due to
the nature of these arrangements, the future potential payments are
inherently uncertain, and accordingly no amounts have been recorded on our Consolidated Balance Sheets.
Associated with the Pharmion acquisition, the Company assumed several agreements that contain
future contractual obligations. A summary of these future commitments is provided below:
Inventory Purchase Commitments. Pharmion entered into product supply contracts under which the
Company provides its suppliers with rolling 12-24 month supply forecasts, with the initial 3-6
month periods representing binding purchase commitments. These commitments totaled $13.9 million
at September 30, 2008.
22
Research and Development. In December 2005, Pharmion entered into a co-development and licensing
agreement for satraplatin with GPC Biotech. Pursuant to the agreement, as assumed, the Company was
required to provide up to $22.2 million for future development costs. In July 2008, the Company
notified the European Medicines Agency, or EMEA, of its decision to withdraw its application for
Marketing Authorization of ORPLATNA®, or satraplatin, 10 mg and 50 mg capsules intended
for use in combination with prednisone, or prednisolone, in the treatment of patients with
metastatic hormone-refractory prostate cancer, or HRPC, who have failed prior chemotherapy. This
withdrawal was based on the position taken by the EMEAs Committee for Medicinal Products for Human
Use that the data provided do not allow them to conclude a positive benefit-risk balance for
ORPLATNA® for the treatment of patients with metastatic HRPC who have failed prior
chemotherapy. In August 2008, the Company notified GPC Biotech of its decision to terminate all of
the existing agreements between the parties, including the satraplatin co-development and license
agreement. On September 30, 2008, the Company and GPC Biotech executed a termination agreement,
with the Company paying GPC Biotech $1.4 million in full satisfaction of its obligations to pay any
past or future satraplatin development costs. This contract termination was included in the
restructuring reserve established as part of the Pharmion acquisition on March 7, 2008 as a portion
of the accrued contract termination costs of $45.0 million.
Contingent Product Acquisition Payments. Pharmion had entered into contractual payment
obligations, the amount and timing of which are contingent upon future events. Under a license and
collaboration agreement with MethylGene Inc., or MethylGene, milestone payments for MGCD0103 of up
to $141.0 million would be payable, based on the achievement of significant development, regulatory
and sales goals. Furthermore, up to $100.0 million in additional payments may be due for each
additional HDAC inhibitor, based on the achievement of significant development, regulatory and
sales milestones. In September 2008, MethylGene exercised its right to convert to a royalty stream
and milestone arrangement with the Company for MGCD0103 as provided under the license and
collaboration agreement between the companies. As a result, MethylGene, following a 90-day
transition period, would no longer be responsible for funding development costs required to obtain
market approval for MGCD0103, and the Company would assume all of the program costs for the
licensed territories, in addition to the possible milestone payments. The enrollment of new
patients into clinical trials evaluating MGCD0103 has been currently suspended. In October 2008,
the Company notified MethylGene of its decision to terminate the license and collaboration agreement
between the parties, eliminating the potential for future royalty or
milestone payments. Following a 90-day transition period, the Company will no longer be
responsible for funding development costs required to obtain market approval for MGCD0103.
Under the terms of an agreement with Cabrellis Pharmaceuticals Corporation, the Company will pay
$12.5 million for each approval of amrubicin by regulatory authorities in the United States and the
European Union. Upon approval of amrubicin for a second indication in the United States or
European Union, the Company will pay an additional payment of $10.0 million for each market. Under
the terms of the license agreement for amrubicin, the Company is required to make milestone
payments of $7.0 million and $1.0 million to Dainippon Sumitomo Pharma Co. Ltd. upon regulatory
approval of amrubicin in the United States and the European Union, respectively, and up to $17.5
million upon achieving certain annual sales levels in the United States. In September 2008,
amrubicin was granted Fast Track product designation by the U.S. Food and Drug Administration for
the treatment of small cell lung cancer after first-line chemotherapy.
23
15. Subsequent Events
On October 3, 2008 the Company entered into an agreement relating to the June 7, 2001 5-azacytidine
license agreement with Pharmacia & Upjohn, now part of Pfizer, Inc., pursuant to which the Company
obtained rights for VIDAZA® as part of the acquisition of Pharmion. Pursuant to the
agreement the Company obtained a perpetual, fully paid-up license to the 5-azacytidine technology
in exchange for a payment of $425.0 million.
On October 24, 2008 VIDAZA® received a positive opinion from the EMEAs Committee for
Medicinal Products for Human Use, or CHMP, for the treatment of adult patients who are not eligible
for haematopoietic stem cell transplantation with intermediate-2and high-risk MDS according to the
International Prognostic Scoring System, chronic myelomonocytic leukemia with 10-29 percent marrow
blasts without myeloproliferative disorder and acute myeloid Leukemia with 20-30 percent blasts and
multi-lineage dysplasia, according to World Health Organization classification.
24
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Information
Certain statements contained or incorporated by reference in this Quarterly Report on Form 10-Q are
forward-looking statements concerning our business, results of operations, economic performance and
financial condition based on our current expectations. These forward-looking statements are not
guarantees of future performance and involve risks and uncertainties that could cause actual
results to differ materially from those implied by such forward-looking statements. Given these
risks and uncertainties, you are cautioned not to place undue reliance on any forward-looking
statements.
Executive Summary
Celgene Corporation and its subsidiaries (collectively we or our) is a global integrated
biopharmaceutical company primarily engaged in the discovery, development and commercialization of
innovative therapies designed to treat cancer and immune-inflammatory related diseases. Our
primary commercial stage products are REVLIMID® (lenalidomide), THALOMID® /
Thalidomide and VIDAZA® (azacitidine for injection). REVLIMID® was approved
by the U.S. Food and Drug Administration, or FDA, the European Commission, or the EC, the Swiss
Agency for Therapeutic Products, or Swissmedic, the Australian Therapeutic Goods Administration, or
TGA, and in October 2008 by Health Canada for treatment in combination with dexamethasone for
multiple myeloma patients who have received at least one prior therapy. In addition,
REVLIMID® was approved by the FDA and the Canadian Therapeutic Products Directorate for
treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk
myelodysplastic syndromes, or MDS, associated with a deletion 5q cytogenetic abnormality with or
without additional cytogenetic abnormalities. We are now launching REVLIMID® in the
European markets and preparing to launch in Canada and Australia. THALOMID® was
approved by the FDA for treatment in combination with dexamethasone for patients with newly
diagnosed multiple myeloma and is also approved for the treatment and suppression of cutaneous
manifestations of erythema nodosum leprosum, or ENL, an inflammatory complication of leprosy. In
April 2008, the TGA approved a supplemental filing granting Thalidomide Pharmion®
marketing approval for use in combination with melphalan and prednisone for patients with untreated
multiple myeloma or ineligible for high dose chemotherapy and also granted Thalidomide
Pharmion® marketing approval in combination with dexamethasone for induction therapy
prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients
with untreated multiple myeloma. In addition, in April 2008, Thalidomide Pharmion® was
granted full marketing authorization by the EC for use in combination with melphalan and prednisone
as a treatment for patients with newly diagnosed multiple myeloma. VIDAZA® is a
pyrimidine nucleoside analog that has been shown to reverse the effects of DNA hypermethylation and
promote subsequent gene re-expression. VIDAZA® was licensed from Pharmacia & Upjohn,
now part of Pfizer, Inc., and was approved by the FDA for the treatment of all subtypes of MDS.
Additionally, VIDAZA® was granted orphan drug designation by the FDA for the treatment
of acute myeloid leukemia. We sell ALKERAN® in the United States, which we obtain
through a supply and distribution agreement with GlaxoSmithKline, or GSK. The agreement with GSK
expires in March 2009 and the current expectation is that it will not be renewed. Subsequent to
expiration of the agreement, GSK will be required to pay Celgene a royalty on sales of the product
made by GSK for the first 24 months following expiration. We also sell FOCALIN®, which
we sell exclusively to Novartis Pharma AG, or Novartis. Another source of revenue is derived from
royalties which we primarily receive from Novartis on its sales of the entire family of
RITALIN® drugs and FOCALIN XR®.
In the second quarter of 2008, we received FDA and the European Medicines Agency, or EMEA,
clearance to open our new manufacturing facility in Switzerland. This state of the art facility
provides us with operational and financial advantages for delivering REVLIMID® and
potentially other oral therapies to patients worldwide.
25
On March 7, 2008, we acquired all of the outstanding common stock and stock options of Pharmion
Corporation in a transaction accounted for under the purchase method of accounting. Under the
purchase method of accounting, the assets and liabilities of Pharmion were recorded as of the
acquisition date, at their respective fair values, and consolidated with our financial statements.
Prior to the acquisition, Pharmion was a global biopharmaceutical company that acquired, developed
and commercialized innovative products for the treatment of hematology and oncology patients. We
acquired Pharmion to enhance our portfolio of therapies for patients with life-threatening
illnesses worldwide with the addition of Pharmions marketed products, and several products in
development for the treatment of hematological and solid tumor cancers. Pharmions results of
operations are included in our consolidated financial statements from the date of acquisition. The
purchase price, including acquisition-related fees and all other costs, as determined on March 7,
2008 was $2.761 billion and includes the previously owned Pharmion shares at historical cost. This
amount was based on the total number of Pharmion shares outstanding, including Pharmion shares
owned by Celgene at that time and Pharmion stock options outstanding.
The impact of purchase accounting, based on a preliminary valuation, resulted in charges in the
nine-month period ended September 30, 2008 including $1.74 billion for acquired in-process research
and development (IPR&D), $76.2 million for amortization of acquired intangible assets which are
being amortized over a weighted average period of 6.5 years, and $18.7 million of the $25.0 million
related to the step-up to fair value of Pharmions product inventory. The $1.74 billion IPR&D
charge related to various research and development projects which had not been completed and for
which there was no alternative future use. The amount of the charge was determined by estimating
the risk-adjusted future value of these projects discounted at rates between 9 percent and 11
percent.
We are dedicated to innovative research and development designed to bring new therapies to market
and are involved in research in several scientific areas that may deliver proprietary
next-generation therapies, such as intracellular signaling, immunomodulation and placental stem
cell research. The drug and cell therapies we develop are designed to treat life-threatening
diseases or chronic debilitating conditions where patients are poorly served by current therapies.
Building on our growing knowledge of the biology underlying hematological and solid tumor cancers
and immune-inflammatory diseases, we are investing in a range of innovative therapeutic programs
that are investigating ways to treat and manage chronic diseases by targeting the disease source
through multiple mechanisms of action. In March 2008, amrubicin, a third-generation fully
synthetic anthracyclin obtained in the Pharmion acquisition, was granted orphan drug designation by
the FDA for the treatment of small cell lung cancer. In September 2008, amrubicin was granted Fast
Track product designation by the FDA for the treatment of small cell lung cancer after first-line
chemotherapy. A drug designated as a Fast Track product is intended for the treatment of a serious
or life-threatening condition and demonstrates the potential to provide a therapy where none exists
or provide a therapy which may offer a significant improvement in safety and/or effectiveness over
existing therapy. Celgene Cellular Therapeutics has successfully filed an Investigational New
Drug, or IND, application with the FDA for its human placenta derived cell product (PDA001). This
filing will allow a multi-center Phase I clinical trial in patients with moderate-to-severe Crohns
disease refractory to oral corticosteroids and immune suppressants to proceed.
Our future growth and operating results will depend on the successful integration of Pharmion,
continued acceptance of our currently marketed products, regulatory approvals of both new products
and expanded use of existing products, depth of our product pipeline and ability to commercialize
these products, competition to our marketed products and challenges to our intellectual property.
See also Risk Factors contained in Part I, Item 1A of our Annual Report on Form 10-K for the year
ended December 31, 2007 and Part II, Item 1A on Form 10-Q for the quarter ended March 31, 2008.
26
The following tables summarize total revenues and earnings for the three- and nine-month periods
ended September 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
Percent |
|
(Amounts in thousands, except earnings per share) |
|
2008 |
|
|
2007 |
|
|
Increase |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
592,465 |
|
|
$ |
349,908 |
|
|
$ |
242,557 |
|
|
|
69.3 |
% |
Net income |
|
$ |
136,814 |
|
|
$ |
38,833 |
|
|
$ |
97,981 |
|
|
|
252.3 |
% |
Diluted earnings per share |
|
$ |
0.29 |
|
|
$ |
0.09 |
|
|
$ |
0.20 |
|
|
|
222.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Periods Ended |
|
|
|
|
|
|
|
|
|
September 30, |
|
|
Increase |
|
|
Percent |
|
|
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
1,626,527 |
|
|
$ |
991,230 |
|
|
$ |
635,297 |
|
|
|
64.1 |
% |
Net (loss) income |
|
$ |
(1,384,391 |
) |
|
$ |
151,112 |
|
|
$ |
(1,535,503 |
) |
|
|
N/A |
|
Diluted (losses) earnings per share |
|
$ |
(3.17 |
) |
|
$ |
0.36 |
|
|
$ |
(3.53 |
) |
|
|
N/A |
|
The increase in revenue for the comparative three- and nine-month periods above
reflect the continued growth of REVLIMID® and inclusion of sales of former Pharmion
products. The net loss in the nine-month period ended September 30, 2008 was primarily due to an
in-process research and development charge and amortization of acquisition intangibles related to
our acquisition of Pharmion in March 2008, which offset the favorable impact of increased revenues.
Results of Operations:
Three-Month Periods Ended September 30, 2008 and 2007
Total Revenue: Total revenue and related percentages for the three-month periods ended September
30, 2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
|
|
|
|
|
|
September 30, |
|
|
Increase |
|
|
Percent |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID® |
|
$ |
342,620 |
|
|
$ |
199,261 |
|
|
$ |
143,359 |
|
|
|
71.9 |
% |
THALOMID® / Thalidomide |
|
|
132,368 |
|
|
|
110,730 |
|
|
|
21,638 |
|
|
|
19.5 |
% |
VIDAZA® |
|
|
63,531 |
|
|
|
|
|
|
|
63,531 |
|
|
|
N/A |
|
ALKERAN® |
|
|
21,802 |
|
|
|
18,858 |
|
|
|
2,944 |
|
|
|
15.6 |
% |
Other |
|
|
6,696 |
|
|
|
2,320 |
|
|
|
4,376 |
|
|
|
188.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net product sales |
|
$ |
567,017 |
|
|
$ |
331,169 |
|
|
$ |
235,848 |
|
|
|
71.2 |
% |
Collaborative agreements and
other revenue |
|
|
2,402 |
|
|
|
4,616 |
|
|
|
(2,214 |
) |
|
|
-48.0 |
% |
Royalty revenue |
|
|
23,046 |
|
|
|
14,123 |
|
|
|
8,923 |
|
|
|
63.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
592,465 |
|
|
$ |
349,908 |
|
|
$ |
242,557 |
|
|
|
69.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27
REVLIMID® net sales increased for the three-month period ended September 30, 2008
compared to the three-month period ended September 30, 2007 primarily due to increased unit sales
in the United States and international markets. Increased market penetration and the increase in
duration of patients using REVLIMID® in multiple myeloma accounted for most of the U.S.
growth. International sales in the 2008 three-month period reflect the expansion of our
international commercial activities in over 65 countries.
THALOMID® / Thalidomide net sales increased for the three-month period ended September
30, 2008 compared to the three-month period ended September 30, 2007 primarily due to the inclusion
of 2008 sales recorded by former Pharmion entities.
VIDAZA® was acquired as part of the purchase of Pharmion effective March 7, 2008.
ALKERANâ net sales were higher for the three-month period ended September 30, 2008
compared to the three-month period ended September 30, 2007 primarily due to an increase in unit
sales of the injectable form.
Net product sales for the three-month period ended September 30, 2008 increased $235.8 million, or
71.2%, compared to the three-month period ended September 30, 2007. The change was comprised of
net volume increases of $204.1 million, or 61.7%, as well as price increases of $27.6 million, or
8.3%, and impact of foreign exchange of $4.1 million or 1.2%.
Collaborative Agreements and Other Revenue: Revenues from collaborative agreements and other
sources declined by $2.2 million for the three-month period ended September 30, 2008 compared to
the three-month period ended September 30, 2007 due to the elimination of license fees and
amortization of deferred revenues related to Pharmion.
Royalty Revenue: Royalty revenue totaled $23.0 million for the three-month period ended September
30, 2008, representing an increase of $8.9 million, compared to the three-month period ended
September 30, 2007. The increase was primarily due to amounts received from Novartis on sales of
the entire family of RITALIN® drugs and FOCALIN XR®. Royalty revenue for the
three-month period ended September 30, 2007 was unfavorably impacted by a decline in Novartis
sales volume which was impacted by a drawdown of its wholesalers inventories.
Gross to Net Sales Accruals: We record gross to net sales accruals for sales returns and
allowances; sales discounts; government rebates; and chargebacks and distributor service fees.
|
|
|
We base our sales returns allowance on estimated on-hand retail/hospital inventories,
measured end-customer demand as reported by third-party sources, actual returns history and
other factors, such as the trend experience for lots where product is still being returned
or inventory centralization and
rationalization initiatives conducted by major pharmacy chains, as applicable. If the
historical data we use to calculate these estimates does not properly reflect future
returns, then a change in the allowance would be made in the period in which such a
determination is made and revenues in that period could be materially affected. Under this
methodology, we track actual returns by individual production lots. Returns on closed lots,
that is, lots no longer eligible for return credits, are analyzed to determine historical
returns experience. Returns on open lots, that is, lots still eligible for return credits,
are monitored and compared with historical return trend rates. Any changes from the
historical trend rates are considered in determining the current sales return allowance.
THALOMID® is drop-shipped directly to the prescribing pharmacy and, as a result,
wholesalers do not stock the product. REVLIMID® is distributed primarily through
contracted pharmacies lending itself to tighter controls of inventory quantities within the
supply channel and, thus, resulting in lower returns activity to date. VIDAZA®
and ALKERAN® are sold in the United States to pharmaceutical wholesalers, who in
turn distribute product to physicians, retail pharmacies, hospitals and other institutional
customers. |
|
|
|
Sales discount accruals are based on payment terms extended to customers. |
28
|
|
|
Government rebate accruals are based on estimated payments due to governmental agencies
for purchases made by third parties under various governmental programs. U.S. Medicaid
rebate accruals are based on historical payment data and estimates of future Medicaid
beneficiary utilization applied to the Medicaid unit rebate amount formula established by
the Center for Medicaid and Medicare Services. Certain foreign markets have
government-sponsored programs that require rebates to be paid and accordingly the rebate
accruals are determined primarily on estimated eligible sales. |
|
|
|
Chargebacks and distributor service fees accruals are based on the differentials between
product acquisition prices paid by wholesalers and lower government contract pricing paid
by eligible customers covered under federally qualified programs. Distributor services
accruals are based on contractual fees to be paid to the wholesale distributor for services
provided. On January 28, 2008, the Fiscal Year 2008 National Defense Authorization Act was
enacted, which expands TRICARE to include prescription drugs dispensed by TRICARE retail
network pharmacies. TRICARE rebate accruals reflect this program expansion and are based
on estimated Department of Defense eligible sales multiplied by the TRICARE rebate formula. |
See Critical Accounting Policies for further discussion of gross to net sales accruals.
Gross to net sales accruals and the balance in the related allowance accounts for the three-month
periods ended September 30, 2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
|
|
|
|
Chargebacks |
|
|
|
|
(Amounts in thousands) |
|
and |
|
|
|
|
|
|
Government |
|
|
and Dist. |
|
|
|
|
2008 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
Service Fees |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2008 |
|
$ |
17,949 |
|
|
$ |
3,195 |
|
|
$ |
23,481 |
|
|
$ |
20,571 |
|
|
$ |
65,196 |
|
Allowances for sales during 2008 |
|
|
948 |
|
|
|
9,065 |
|
|
|
9,579 |
|
|
|
22,514 |
|
|
|
42,106 |
|
Credits/deductions issued for
prior year sales |
|
|
(2,439 |
) |
|
|
|
|
|
|
(44 |
) |
|
|
(22 |
) |
|
|
(2,505 |
) |
Credits/deductions issued for
sales during 2008 |
|
|
(686 |
) |
|
|
(9,188 |
) |
|
|
(9,319 |
) |
|
|
(22,996 |
) |
|
|
(42,189 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2008 |
|
$ |
15,772 |
|
|
$ |
3,072 |
|
|
$ |
23,697 |
|
|
$ |
20,067 |
|
|
$ |
62,608 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
|
|
|
|
Chargebacks |
|
|
|
|
(Amounts in thousands) |
|
and |
|
|
|
|
|
|
Government |
|
|
and Dist. |
|
|
|
|
2007 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
Service Fees |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2007 |
|
$ |
14,944 |
|
|
$ |
2,617 |
|
|
$ |
9,167 |
|
|
$ |
9,058 |
|
|
$ |
35,786 |
|
Allowances for sales during 2007 |
|
|
4,015 |
|
|
|
7,640 |
|
|
|
6,626 |
|
|
|
19,083 |
|
|
|
37,364 |
|
Allowances for sales during
prior periods |
|
|
6,022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,022 |
|
Credits/deductions issued for
prior year sales |
|
|
(4,010 |
) |
|
|
(23 |
) |
|
|
(29 |
) |
|
|
|
|
|
|
(4,062 |
) |
Credits/deductions issued for
sales during 2007 |
|
|
(1,545 |
) |
|
|
(7,151 |
) |
|
|
(5,930 |
) |
|
|
(16,514 |
) |
|
|
(31,140 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2007 |
|
$ |
19,426 |
|
|
$ |
3,083 |
|
|
$ |
9,834 |
|
|
$ |
11,627 |
|
|
$ |
43,970 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29
A comparison of allowances for sales within each of the four categories noted above for the
three-month periods ended September 30, 2008 and 2007, respectively, follows:
Returns and allowances decreased by $9.1 million for the three-month period ended September 30,
2008 compared to the three-month period ended September 30, 2007 primarily due to reduced
THALOMID® inventory in the sales channel due to the 2007 THALOMID® inventory
centralization and rationalization at several major pharmacy chains, which also resulted in
additional returns during 2007. In addition, the 2007 period includes an increase in
THALOMID® returns resulting from the anticipated increase in use of REVLIMID®
in multiple myeloma.
Discounts increased by $1.4 million for the three-month period ended September 30, 2008 compared to
the three-month period ended September 30, 2007 primarily due to increased sales of
REVLIMIDâ, as well as the inclusion of former Pharmion products, which resulted in
additional discounts taken.
Government rebates increased by $3.0 million in the three-month period ended September 30, 2008
compared to the three-month period ended September 30, 2007 primarily due to the increased
international government rebates resulting from our global expansion, as well as the inclusion of
former Pharmion products.
Chargebacks and distributor service fees increased by $3.4 million in the three-month period ended
September 30, 2008 compared to the three-month period ended September 30, 2007 primarily due the
new TRICARE rebate program, as well as the inclusion of former Pharmion products.
Operating Costs and Expenses: Operating costs, expenses and related percentages for the
three-month periods ended September 30, 2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
Percent |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
Increase |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding
amortization expense) |
|
$ |
70,534 |
|
|
$ |
34,066 |
|
|
$ |
36,468 |
|
|
|
107.1 |
% |
Percent of net product sales |
|
|
12.4 |
% |
|
|
10.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
160,911 |
|
|
$ |
130,841 |
|
|
$ |
30,070 |
|
|
|
23.0 |
% |
Percent of total revenue |
|
|
27.2 |
% |
|
|
37.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
$ |
168,607 |
|
|
$ |
94,736 |
|
|
$ |
73,871 |
|
|
|
78.0 |
% |
Percent of total revenue |
|
|
28.5 |
% |
|
|
27.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets |
|
$ |
32,833 |
|
|
$ |
2,290 |
|
|
$ |
30,543 |
|
|
|
N/A |
|
Cost of Goods Sold (excluding amortization expense): Cost of goods sold increased by $36.5 million
for the three-month period ended September 30, 2008 compared to the three-month period ended
September 30, 2007 primarily due to increased unit volume for REVLIMIDâ, increased
material costs for ALKERANâ for injection and the inclusion of $35.3 million in
cost of sales related to former Pharmion products, particularly VIDAZAâ and
Thalidomide Pharmionâ, including $7.5 million of the $25.0 million of inventory
step-up. As a percent of net product sales, cost of goods sold (excluding amortization expense)
increased to 12.4% in the 2008 three-month period from 10.3% in the 2007 three-month period
primarily due to the inclusion of higher costs for VIDAZAâ and
ALKERANâ and the $7.5 million of inventory step-up.
30
Research and Development: Research and development expenses increased by $30.1 million for the
three-month period ended September 30, 2008 compared to the three-month period ended September 30,
2007, primarily due to the increase in spending related to clinical research and development in
support of multiple programs, including REVLIMIDâ, other IMiDsâ
and other compounds across a broad range of diseases, the inclusion of expenses for former Pharmion
entities which were partly related to amrubicin , increased spending for regulatory
affairs primarily due to the expansion of REVLIMIDâ in international markets and
the collaborative arrangement with Acceleron Pharma Inc., or Acceleron. The increase was partly
offset by the 2007 inclusion of a combined $41.1 million in upfront payments for collaborative
research and development arrangements for early stage compounds with Array BioPharma Inc., or
Array, and PTC Therapeutics, or PTC.
The following table provides an additional breakdown of research and development expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
|
|
|
September 30, |
|
|
Increase |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Human pharmaceutical clinical programs |
|
$ |
83,347 |
|
|
$ |
32,700 |
|
|
$ |
50,647 |
|
Other pharmaceutical programs |
|
|
60,959 |
|
|
|
83,868 |
|
|
|
(22,909 |
) |
Biopharmaceutical discovery and development |
|
|
12,165 |
|
|
|
10,360 |
|
|
|
1,805 |
|
Placental stem cell and biomaterials |
|
|
4,440 |
|
|
|
3,913 |
|
|
|
527 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
160,911 |
|
|
$ |
130,841 |
|
|
$ |
30,070 |
|
|
|
|
|
|
|
|
|
|
|
Other pharmaceutical programs for the three-month periods ended September 30, 2008 and 2007 include
spending for toxicology, analytical research and development, drug discovery, quality and
regulatory affairs. Spending for the three-month period ended September 30, 2007 includes a combined $41.1 million in
upfront payments for collaborative research and development arrangements for early stage compounds
with Array and PTC.
Research and development expenditures support ongoing clinical progress in multiple proprietary
development programs for REVLIMIDâ and other IMiDsâ
compounds; for VIDAZAâ; amrubicin, our lead compound for small cell lung cancer;
apremilast (CC-10004), our lead anti-inflammatory compound that inhibits PDE-4, which results in
the inhibition of multiple proinflammatory mediators such as TNF-α and which is currently being
evaluated in Phase II clinical trials in the treatment of psoriasis and psoriatic arthritis;
CC-4047, CC-11006 and CC-11050, which are currently either being evaluated in Phase I clinical
trials or for which Phase II clinical trials are planned or ongoing; and our kinase and ligase
inhibitor programs as well as the placental stem cell program. The Company and Acceleron have
initiated Phase II studies of ACE-011 in multiple myeloma patients suffering from cancer-related
bone loss.
Selling, General and Administrative: Selling, general and administrative expenses increased by
$73.9 million for the three-month period ended September 30, 2008 compared to the three-month
period ended September 30, 2007, primarily reflecting an increase in marketing expenses of $27.4
million, sales force costs of $14.3 million, administrative expenses of $20.5 million and donations
to non-profit foundations of $7.9 million. The increase reflects the integration of the former
Pharmion commercial organization, marketing and sales expenses related to ongoing product launch
activities for REVLIMIDâ and Thalidomide in Europe, Canada and Australia. The
increase also reflects the activities related to the relaunch of VIDAZAâ in the
United States after obtaining an expanded FDA approval to reflect new overall survival achieved in
the AZA-001 survival study of patients with higher-risk MDS and launch in Europe. The increase in
expense also reflects the continued expansion of our international commercial activities in over 65
countries.
31
Amortization of Acquired Intangible Assets: The $32.8 million in amortization of acquired
intangible assets for the three-month period ended September 30, 2008 related to intangible assets
resulting from the March 2008 acquisition of Pharmion. The $2.3 million amortization of
acquisition intangibles for the three-month period ended September 30, 2007 related to the
acquisition of Penn T Limited.
Interest and Investment Income, Net: Interest and investment income was $19.7 million for the
three-month period ended September 30, 2008, representing a decrease of $8.6 million from the $28.3
million recorded for the three-month period ended September 30, 2007. The decrease was due to
lower average cash, cash equivalents and marketable securities balances resulting from the cash
payout related to the Pharmion acquisition coupled with reduced yields on invested balances. The
three-month period ended September 30, 2007 included other-than-temporary impairment losses on
marketable securities available for sale of $1.8 million.
Equity in Losses of Affiliated Companies: Under the equity method of accounting, we recorded
losses of $2.3 million and $1.1 million for the three-month periods ended September 30, 2008 and
2007, respectively. The $1.2 million increase in losses for the three-month period ended September
30, 2008 was primarily due to an impairment charge of $1.6 million. This impairment loss was based
on an evaluation of several factors, including a decrease in fair value of the equity investment
below our cost.
Interest Expense: Interest expense was $0.5 million and $2.6 million for the three-month periods
ended September 30, 2008 and 2007, respectively. The $2.1 million decrease reflects the conversion
of convertible debt into our common stock that was completed in June 2008.
Other Income (Expense), Net: Other income, net was income of $2.5 million and $0.7 million for the
three-month periods ended September 30, 2008 and 2007, respectively. The $1.8 million increase in
other income
was due to foreign exchange gains partly offset by an other-than-temporary impairment loss on an
equity investment.
Income Tax Provision: The income tax provision for the three-month period ended September 30, 2008
was $42.1 million with an effective tax rate of 23.5% which reflects the growth of our low tax
Swiss manufacturing operations and our overall global mix of income. The income tax provision for
the three-month period ended September 30, 2007 was $74.5 million with an effective tax rate of
65.7%. The income tax provision for the three-month period ended September 30, 2007 reflected the
impact of certain expenses incurred in taxing jurisdictions outside the United States for which we
did not receive a tax benefit, nondeductible expenses which included share-based compensation
expense related to incentive stock options, and a tax expense of approximately $4.0 million to
adjust deferred tax assets and liabilities for the effect of changes in tax rates.
32
Results of Operations:
Nine-Month Periods Ended September 30, 2008 and 2007
Total Revenue: Total revenue and related percentages for the nine-month periods ended September
30, 2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Periods Ended |
|
|
|
|
|
|
|
|
|
September 30, |
|
|
Increase |
|
|
Percent |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID® |
|
$ |
955,226 |
|
|
$ |
526,457 |
|
|
$ |
428,769 |
|
|
|
81.4 |
% |
THALOMID® / Thalidomide |
|
|
377,869 |
|
|
|
334,472 |
|
|
|
43,397 |
|
|
|
13.0 |
% |
VIDAZA® |
|
|
137,027 |
|
|
|
|
|
|
|
137,027 |
|
|
|
N/A |
|
ALKERAN® |
|
|
57,329 |
|
|
|
53,560 |
|
|
|
3,769 |
|
|
|
7.0 |
% |
Other |
|
|
14,105 |
|
|
|
5,421 |
|
|
|
8,684 |
|
|
|
160.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net product sales |
|
$ |
1,541,556 |
|
|
$ |
919,910 |
|
|
$ |
621,646 |
|
|
|
67.6 |
% |
Collaborative agreements and
other revenue |
|
|
9,960 |
|
|
|
14,520 |
|
|
|
(4,560 |
) |
|
|
-31.4 |
% |
Royalty revenue |
|
|
75,011 |
|
|
|
56,800 |
|
|
|
18,211 |
|
|
|
32.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
1,626,527 |
|
|
$ |
991,230 |
|
|
$ |
635,297 |
|
|
|
64.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID® net sales increased for the nine-month period ended September 30, 2008
compared to the nine-month period ended September 30, 2007 primarily due to increased unit sales in
the United States and international markets. Increased market penetration and the increase in
duration of patients using REVLIMID® in multiple myeloma accounted for most of the U.S.
growth. International sales in the 2008 nine-month period reflect the full period impact of the
June 2007 ECs approval for the use of REVLIMID® for treatment in combination with
dexamethasone of patients with multiple myeloma who have received at least one prior therapy and
continued expansion in international markets.
THALOMID® / Thalidomide net sales increased for the nine-month period ended September
30, 2008 compared to the nine-month period ended September 30, 2007 primarily due to the inclusion
of 2008 sales recorded by former Pharmion entities.
VIDAZA® was acquired as part of the purchase of Pharmion effective March 7, 2008.
ALKERANâ net sales were slightly higher for the nine-month period ended September
30, 2008 compared to the nine-month period ended September 30, 2007 primarily due to an increase in
unit sales of the injectable form.
Net product sales for the nine-month period ended September 30, 2008 increased $621.6 million, or
67.6%, compared to the nine-month period ended September 30, 2007. The change was comprised of net
volume increases of $532.0 million, or 57.8%, as well as price increases of $73.9 million, or 8.1%, and
impact of foreign exchange of $15.7 million, or 1.7%.
Collaborative Agreements and Other Revenue: Revenues from collaborative agreements and other
sources decreased by $4.6 million for the nine-month period ended September 30, 2008 compared to
the nine-month period ended September 30, 2007, due to the elimination of license fees and
amortization of deferred revenues related to Pharmion.
33
Royalty Revenue: Royalty revenue totaled approximately $75.0 million for the nine-month period
ended September 30, 2008, representing an increase of $18.2 million compared to the nine-month
period ended September 30, 2007. The increase was primarily due to amounts received from Novartis
on sales of FOCALIN XR®, partly due to a transition of patients from
FOCALIN®, which the Company sells directly to Novartis.
Gross to Net Sales Accruals: Gross to net sales accruals and the balance in the related allowance
accounts for the nine-month periods ended September 30, 2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
|
|
|
|
Chargebacks |
|
|
|
|
(Amounts in thousands) |
|
and |
|
|
|
|
|
|
Government |
|
|
and Dist. |
|
|
|
|
2008 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
Service Fees |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
$ |
16,734 |
|
|
$ |
2,895 |
|
|
$ |
9,202 |
|
|
$ |
8,839 |
|
|
$ |
37,670 |
|
Pharmion balance at March 7, 2008 |
|
|
926 |
|
|
|
283 |
|
|
|
1,266 |
|
|
|
2,037 |
|
|
|
4,512 |
|
Allowances for sales during 2008 |
|
|
15,542 |
|
|
|
26,176 |
|
|
|
39,120 |
|
|
|
74,243 |
|
|
|
155,081 |
|
Credits/deductions issued for
prior year sales |
|
|
(15,257 |
) |
|
|
(2,427 |
) |
|
|
(7,951 |
) |
|
|
(4,128 |
) |
|
|
(29,763 |
) |
Credits/deductions issued for
sales during 2008 |
|
|
(2,173 |
) |
|
|
(23,855 |
) |
|
|
(17,940 |
) |
|
|
(60,924 |
) |
|
|
(104,892 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2008 |
|
$ |
15,772 |
|
|
$ |
3,072 |
|
|
$ |
23,697 |
|
|
$ |
20,067 |
|
|
$ |
62,608 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
|
|
|
|
Chargebacks |
|
|
|
|
(Amounts in thousands) |
|
and |
|
|
|
|
|
|
Government |
|
|
and Dist. |
|
|
|
|
2007 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
Service Fees |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
$ |
9,480 |
|
|
$ |
2,296 |
|
|
$ |
7,468 |
|
|
$ |
10,633 |
|
|
$ |
29,877 |
|
Allowances for sales during 2007 |
|
|
15,165 |
|
|
|
20,036 |
|
|
|
20,858 |
|
|
|
52,303 |
|
|
|
108,362 |
|
Allowances for sales during
prior periods |
|
|
13,522 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,522 |
|
Credits/deductions issued for
prior year sales |
|
|
(14,517 |
) |
|
|
(2,206 |
) |
|
|
(7,060 |
) |
|
|
(6,725 |
) |
|
|
(30,508 |
) |
Credits/deductions issued for
sales during 2007 |
|
|
(4,224 |
) |
|
|
(17,043 |
) |
|
|
(11,432 |
) |
|
|
(44,584 |
) |
|
|
(77,283 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2007 |
|
$ |
19,426 |
|
|
$ |
3,083 |
|
|
$ |
9,834 |
|
|
$ |
11,627 |
|
|
$ |
43,970 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A comparison of allowances for sales within each of the four categories noted above for the
nine-month periods ended September 30, 2008 and 2007, respectively, follows:
Returns and allowances decreased by $13.1 million for the nine-month period ended September 30,
2008 compared to the nine-month period ended September 30, 2007 primarily due to reduced
THALOMID® inventory in the sales channel due to the 2007 THALOMID® inventory
centralization and rationalization at several major pharmacy chains, which also resulted in
additional returns during 2007. In addition, the 2007 period includes an increase in
THALOMID® returns resulting from the anticipated increase in use of REVLIMID®
in multiple myeloma.
Discounts increased by $6.1 million for the nine-month period ended September 30, 2008 compared to
the nine-month period ended September 30, 2007 primarily due to increased sales of
REVLIMIDâ as well as the inclusion of former Pharmion products, which resulted in
additional discounts taken.
Government rebates increased by $18.3 million in the nine-month period ended September 30, 2008
compared to the nine-month period ended September 30, 2007 primarily due to the increased
international government rebates resulting from our global expansion, as well as the inclusion of
former Pharmion products.
34
Chargebacks and distributor service fees increased by $21.9 million in the nine-month period ended
September 30, 2008 compared to the nine-month period ended September 30, 2007 primarily due to the
new TRICARE rebate program, as well as the inclusion of former Pharmion products.
Operating Costs and Expenses: Operating costs, expenses and related percentages for the nine-month
periods ended September 30, 2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Period Ended |
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
Percent |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
Increase |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization
expense) |
|
$ |
190,452 |
|
|
$ |
84,840 |
|
|
$ |
105,612 |
|
|
|
124.5 |
% |
Percent of net product sales |
|
|
12.4 |
% |
|
|
9.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
462,650 |
|
|
$ |
301,341 |
|
|
$ |
161,309 |
|
|
|
53.5 |
% |
Percent of total revenue |
|
|
28.4 |
% |
|
|
30.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
$ |
485,345 |
|
|
$ |
310,669 |
|
|
$ |
174,676 |
|
|
|
56.2 |
% |
Percent of total revenue |
|
|
29.8 |
% |
|
|
31.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets |
|
$ |
77,842 |
|
|
$ |
6,755 |
|
|
$ |
71,087 |
|
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process research and development |
|
$ |
1,740,000 |
|
|
$ |
|
|
|
$ |
1,740,000 |
|
|
|
N/A |
|
Cost of Goods Sold (excluding amortization expense): Cost of goods sold increased by $105.6
million for the nine-month period ended September 30, 2008 compared to the nine-month period ended
September 30, 2007 primarily due to increased unit volume for REVLIMIDâ, increased
material costs for ALKERANâ for injection and the inclusion of $70.0 million in
cost of sales related to former Pharmion products, particularly VIDAZAâ and
Thalidomide Pharmionâ, including $18.7 million of the $25.0 million of inventory
step-up.
As a percent of net product sales, cost of goods sold (excluding amortization expense) increased to
12.4% in the 2008 nine-month period from 9.2% in the 2007 nine-month period primarily due to the
inclusion of higher costs for VIDAZAâ and ALKERANâ and the $18.7
million of inventory step-up.
Research and Development: Research and development expenses increased by $161.3 million for the
nine-month period ended September 30, 2008 compared to the nine-month period ended September 30,
2007, primarily due to $44.4 million in spending related to clinical research and development in
support of multiple programs, including REVLIMIDâ, other IMiDsâ
and other compounds across a broad range of diseases, increased regulatory spending primarily due
to the expansion of REVLIMIDâ in international markets, the inclusion of expenses
for former Pharmion entities which were partly related to amrubicin and the MethylGene HDAC program
and an increase of $45.0 million in upfront payments made to Acceleron in the 2008 nine-month
period related to a research and development collaboration arrangement. The increase was partly
offset by the 2007 inclusion of a combined $41.1 million in upfront payments for collaborative
research and development arrangements for early stage compounds with Array and PTC.
35
The following table provides an additional breakdown of research and development expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Periods Ended |
|
|
|
|
|
|
September 30, |
|
|
|
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
Increase |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Human pharmaceutical clinical programs |
|
$ |
204,922 |
|
|
$ |
103,390 |
|
|
$ |
101,532 |
|
Other pharmaceutical programs |
|
|
210,349 |
|
|
|
155,737 |
|
|
|
54,612 |
|
Biopharmaceutical discovery and development |
|
|
34,547 |
|
|
|
31,599 |
|
|
|
2,948 |
|
Placental stem cell and biomaterials |
|
|
12,832 |
|
|
|
10,615 |
|
|
|
2,217 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
462,650 |
|
|
$ |
301,341 |
|
|
$ |
161,309 |
|
|
|
|
|
|
|
|
|
|
|
Other pharmaceutical programs for the nine-month period ended September 30, 2008 includes $45.0
million for the Acceleron collaborative research and development arrangement, in addition to
spending for toxicology, analytical research and development, drug discovery, quality and
regulatory affairs. Other pharmaceutical programs for the nine-month period ended September 30,
2007 includes a combined $41.1 million in upfront payments for collaborative research and
development arrangements for early stage compounds with Array and PTC, in addition to spending for
toxicology, analytical research and development, drug discovery, quality and regulatory affairs.
The Company and Acceleron have initiated Phase II studies of ACE-011 in multiple myeloma patients
suffering from cancer-related bone loss.
Selling, General and Administrative: Selling, general and administrative expenses increased by
$174.7 million for the nine-month period ended September 30, 2008 compared to the nine-month period
ended September 30, 2007, primarily reflecting an increase in marketing expenses of $68.6 million,
sales force costs of $42.0 million, and general and administrative expenses of $50.3 million. The
increase reflects the integration of the former Pharmion commercial organization, marketing and
sales expenses related to ongoing product launch activities for REVLIMIDâ and
Thalidomide in Europe, Canada and Australia. The increase also reflects the activities related to
the relaunch of VIDAZAâ in the United States after obtaining an expanded FDA
approval to reflect new overall survival achieved in the AZA-001 survival study of patients with
higher-risk MDS and launch in Europe. The increase in expenses also reflects the continued
expansion of our international commercial activities in over 65 countries.
Amortization of Acquired Intangible Assets: The $77.8 million in amortization of acquired
intangible assets for the nine-month period ended September 30, 2008 included $76.2 million related
to intangible assets resulting from the March 2008 acquisition of Pharmion and $1.6 million
resulting from the October 2004 acquisition of Penn T Limited. The $6.8 million amortization of
acquisition intangibles for the nine-month period ended September 30, 2007 related to the
acquisition of Penn T Limited.
Acquired In-Process Research and Development: IPR&D represents compounds under development by
Pharmion at the date of acquisition that had not yet achieved regulatory approval for marketing in
certain markets or had not yet been completed and have no alternative future use. The $1.74
billion estimated fair value of these intangibles was derived using the multi-period
excess-earnings method, a form of the income approach. The IPR&D primarily related to development
and approval initiatives for VIDAZAâ IV in the EU market, the oral form of
azacitidine in the U.S. and EU markets and Thalidomide Pharmionâ in the EU market.
The projected cash flows for valuation purposes were based on key assumptions such as estimates of
revenues and operating profits related to the programs considering their stages of development; the
time and
resources needed to complete the regulatory approval process for the products; and the life of the
potential commercialized products and associated risks, including the inherent difficulties and
uncertainties in obtaining regulatory approvals.
36
For VIDAZA® IV in the EU market, the related future net cash flows were estimated using
a risk-adjusted discount rate of 10.0% and an anticipated regulatory approval date in late 2008
with market exclusivity rights expected to continue through 2019. For the oral form of azacitidine
in the United States and European Union, the future net cash flows were estimated using a
risk-adjusted discount rate of 11.0% for each market. The anticipated regulatory approval in the
European Union was assumed for 2013 with exclusivity continuing through 2023, and the anticipated
regulatory approval in the United States was assumed for 2013 with exclusivity continuing through
2018. For Thalidomide Pharmion® in the EU market, the future net cash flows were
estimated using a risk-adjusted discount rate of 9.5% and an anticipated regulatory approval date
in 2008 with exclusivity continuing through 2018. In April 2008, Thalidomide Pharmion®
was granted full marketing authorization by the EC for use in combination with melphalan and
prednisone as a treatment for patients with newly diagnosed multiple myeloma.
Interest and Investment Income, Net: Interest and investment income was $69.3 million for the
nine-month period ended September 30, 2008, representing a $10.1 million decrease from the $79.4
million recorded for the nine-month period ended September 30, 2007. The decrease was due to lower
average cash, cash equivalents and marketable securities balances resulting from the cash payout
related to the Pharmion acquisition coupled with reduced yields on invested balances. Interest and
investment income, net included other-than-temporary impairment losses on marketable securities
available for sale of $2.5 million and $3.0 million for the nine-month periods ended September 30,
2008 and 2007, respectively.
Equity in Losses of Affiliated Companies: Under the equity method of accounting, we recorded
losses of $8.8 million and $3.3 million for the nine-month periods ended September 30, 2008 and
2007, respectively. The loss in the nine-month period ended September 30, 2008 included impairment
charges of $6.0 million. The impairment losses were based on an evaluation of several factors,
including a decrease in fair value of the equity investment below our cost.
Interest Expense: Interest expense was $4.0 million and $7.9 million for the nine-month periods
ended September 30, 2008 and 2007, respectively. The $3.9 million decrease was primarily due to
the conversion of convertible debt into our common stock which was completed in June 2008.
Other Income (Expense), Net: Other income (expense), net was income of $5.0 million for the
nine-month period ended September 30, 2008 and expense of $3.3 million for the nine-month period
ended September 30, 2007. The $8.3 million increase in other income was primarily due to foreign
exchange gains in addition to a $1.3 million government grant partly offset by an
other-than-temporary impairment loss on an equity investment. The nine-month period ended
September 30, 2007 also included expenses related to a termination benefit resulting from the
modification of certain outstanding stock options of a terminated employee which was partly offset
by $1.2 million in foreign exchange gains.
Income Tax Provision: The income tax provision for the nine-month period ended September 30, 2008
was $116.1 million with an effective tax rate of negative 9.2%. The effective tax rate was
negatively impacted by non-deductible in-process research and development charges incurred in
connection with the acquisition of Pharmion. The effective tax rate, excluding the impact of the
IPR&D charges, was 24.6% which reflects the growth of our low tax Swiss manufacturing operations
and our overall global mix of income. The income tax provision for the nine-month period ended
September 30, 2007 was $201.4 million with an effective tax rate of 57.1%, and reflected the impact
of certain expenses incurred in taxing jurisdictions outside the United States for which we did not
receive a tax benefit and nondeductible expenses which included share-based compensation expense
related to incentive stock options. The income tax provision for the nine months
ended September 30, 2007 also reflected a tax benefit of approximately $7.0 million related to a
research and experimentation tax credit study covering prior years and a tax expense of
approximately $4.0 million to adjust deferred tax assets and liabilities for the effect of changes
in tax rates.
37
Liquidity and Capital Resources
Cash flows from operating, investing and financing activities for the nine-month periods ended
September 30, 2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Periods Ended |
|
|
|
|
|
|
September 30, |
|
|
Increase |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
$ |
476,344 |
|
|
$ |
310,933 |
|
|
$ |
165,411 |
|
Net cash used in investing activities |
|
$ |
(299,504 |
) |
|
$ |
(962,890 |
) |
|
$ |
663,386 |
|
Net cash provided by financing activities |
|
$ |
166,391 |
|
|
$ |
248,647 |
|
|
$ |
(82,256 |
) |
Operating Activities: Net cash provided by operating activities for the nine-month period ended
September 30, 2008 increased by $165.4 million to $476.3 million as compared to the nine-month
period ended September 30, 2007. The increase in net cash provided by operating activities was
primarily attributable to:
|
|
|
an expansion of our operations; partially offset by |
|
|
|
the timing of receipts and payments in the ordinary course of business. |
Investing Activities: Net cash used in investing activities for the nine-month period ended
September 30, 2008 decreased by $663.4 million to $299.4 million as compared to the nine-month
period ended September 30, 2007. The decrease in net cash used in by investing activities was
primarily attributable to:
|
|
|
net proceeds from sales of marketable securities available for sale as opposed to net
purchases in the prior year period; partially offset by |
|
|
|
the cash paid to acquire Pharmion. |
Financing Activities: Net cash provided by financing activities for the nine-month period ended
September 30, 2008 decreased by $82.3 million to $166.4 million as compared to the nine-month
period ended September 30, 2007. The decrease in net cash provided by financing activities was
primarily attributable to:
|
|
|
a decrease in the proceeds from the exercise of common stock options and warrants; and |
|
|
|
a decrease in the tax benefit from share-based compensation arrangements. |
Cash, Cash Equivalents, Marketable Securities Available for Sale and Working Capital: Cash, cash
equivalents, marketable securities available for sale and working capital as of September 30, 2008
and December 31, 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities available for sale |
|
$ |
2,454,170 |
|
|
$ |
2,738,918 |
|
|
$ |
(284,748 |
) |
Working capital (1) |
|
$ |
2,516,761 |
|
|
$ |
2,835,205 |
|
|
$ |
(318,444 |
) |
|
|
|
(1) |
|
Includes cash, cash equivalents and marketable securities available for sale, accounts
receivable, net of allowances, inventory and other current assets, less accounts payable, accrued
expenses, income taxes payable and other current liabilities. |
Cash, Cash Equivalents and Marketable Securities Available for Sale: We invest our excess cash
primarily in money market funds, mortgage-backed obligations, U.S. Treasury securities and U.S.
government-sponsored agency debt. All liquid investments with maturities of three months or less
from the date of purchase are classified as cash equivalents and all investments with maturities of
greater than three months from the date of purchase are classified as marketable securities
available for sale. We determine the appropriate classification of our investments in marketable
debt and equity securities at the time of purchase. The decrease in cash, cash equivalents and
marketable securities available for sale from December 31, 2007 to September 30, 2008 was primarily
due to the net payment of $746.8 million relating to the Pharmion acquisition, which was partly
offset by increased cash generated from operations.
38
Accounts Receivable, Net: Accounts receivable, net increased by $108.2 million to $275.4 million
as of September 30, 2008 compared to December 31, 2007 partly due to the inclusion of former
Pharmion net receivables and increased sales of REVLIMID®. Days of sales outstanding at
September 30, 2008 amounted to 46 days including former Pharmion net receivables and 43 days
excluding former Pharmion net receivables compared to 41 days at December 31, 2007. Excluding
former Pharmion net receivables, the increase was primarily due to increased international sales
for which the collection period is longer than for U.S. sales.
Inventory: Inventory as of September 30, 2008 of $90.4 million increased by $41.3 million compared
to December 31, 2007 primarily as a result of the addition of VIDAZA® and Thalidomide
Pharmion® inventory from the Pharmion acquisition in addition to an increase in the
inventory levels of all other products.
Other Current Assets: Other current assets increased $35.8 million to $144.5 million as of
September 30, 2008 compared to December 31, 2007 primarily due to the foreign currency forward
hedging contracts entered into during the current quarter, the inclusion of $4.9 million in former
Pharmion assets and an increase in other receivables.
Accounts Payable, Accrued Expenses and Other Current Liabilities: Accounts payable, accrued
expenses and other current liabilities increased $208.4 million to $432.1 million as of September
30, 2008 compared to December 31, 2007. The increase was primarily due to restructuring reserves
of $43.6 million, the inclusion of $96.4 million in former Pharmion liabilities, an increase in
foreign currency forward hedging contracts, an increase in clinical related spending and increased
sales rebate accruals.
Income Taxes Payable (Current and Non-Current): Income taxes payable increased $56.3 million as of
September 30, 2008 compared to December 31, 2007 primarily from provisions for income taxes of
$154.3 million partially offset by tax payments of $28.1 million and a tax benefit on stock option
exercises of $72.7 million.
We expect continued growth in our expenditures, particularly those related to research and product
development, clinical trials, regulatory approvals, international expansion, commercialization of
products and capital investments. However, we anticipate that existing cash, cash equivalents and
marketable securities available for sale, combined with cash received from expected net product
sales and royalty agreements, will provide sufficient capital resources to fund our operations for
the foreseeable future.
Financial Condition
We invest our excess cash primarily in money market funds, mortgage-backed obligations, U.S.
Treasury securities and U.S. government-sponsored agency securities.
U.S. government-sponsored agency securities include issues from the Federal Home Loan Bank, the
Federal National Mortgage Association, or Fannie Mae, and the Federal Home Loan Mortgage
Corporation, or Freddie Mac. All three of these agencies are regulated by the recently established
Federal Housing Finance Agency, or the FHFA. On September 7, 2008, the U.S. government, through
the FHFA and the U.S. Treasury, announced that it was placing both Fannie Mae and Freddie Mac into
conservatorship, with the FHFA assuming their day-to-day operations. On that same day, the U.S.
Treasury established a new secured lending credit facility available to Fannie Mae and Freddie Mac,
which is intended to serve as an ultimate liquidity backstop. This action, in essence, implemented
the temporary liquidity backstop authority granted to the U.S. Treasury by Congress in July 2008,
and will be available until December 2009. These measures were taken with the goal of preserving
the value of the debt and mortgage-backed securities issued by these U.S. government-sponsored
agencies as well as to ensure that these agencies have future access to capital. Celgene has not
recorded any impairments against its holdings in these securities.
39
As of September 30, 2008, our financial assets and liabilities were recorded at fair value. In
accordance with SFAS No. 157, Fair Value Measurement, or SFAS 157, we have classified our
financial assets and liabilities as Level 1, 2 or 3 within the fair value hierarchy. Fair values
determined based on Level 1 inputs utilize quoted prices (unadjusted) in active markets for
identical assets or liabilities. Our Level 1 assets consist of marketable equity securities. Fair
values determined based on Level 2 inputs utilize observable quoted prices for similar assets and
liabilities in active markets and observable quoted prices from identical or similar assets in
markets that are not very active. Our Level 2 assets consist of mortgage-backed obligations, U.S.
Treasury securities, U.S. government-sponsored agency securities, corporate debt securities and
forward currency contracts. Fair values determined based on Level 3 inputs utilize unobservable
inputs and include valuations of assets or liabilities for which there is little, if any, market
activity. Our Level 3 assets consist of a private cash fund.
A majority of our financial assets and liabilities have been classified as Level 2. These assets
and liabilities were initially valued at the transaction price and subsequently valued based on
inputs utilizing observable quoted prices for similar assets and liabilities in active markets and
observable quoted prices from identical or similar assets in markets that are not very active.
The asset with fair values based on Level 3 inputs was the private cash fund, which represents
approximately 1.6 % of total fair value for available-for-sale securities at September 30, 2008.
Contractual Obligations
The following table sets forth our contractual obligations as of September 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment Due By Period |
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
|
More than |
|
|
|
|
(Amounts in thousands) |
|
1 Year |
|
|
1 to 3 Years |
|
|
3 to 5 Years |
|
|
5 Years |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases |
|
$ |
19,595 |
|
|
$ |
36,276 |
|
|
$ |
11,545 |
|
|
$ |
3,232 |
|
|
$ |
70,648 |
|
ALKERAN® supply agreements |
|
|
13,442 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,442 |
|
Manufacturing facility note payable |
|
|
3,660 |
|
|
|
7,320 |
|
|
|
7,142 |
|
|
|
10,713 |
|
|
|
28,835 |
|
Other contract commitments |
|
|
32,734 |
|
|
|
2,051 |
|
|
|
|
|
|
|
|
|
|
|
34,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
69,431 |
|
|
$ |
45,647 |
|
|
$ |
18,687 |
|
|
$ |
13,945 |
|
|
$ |
147,710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other contract commitments include $13.9 million in contractual obligations related to product
supply contracts that were assumed by us with the Pharmion acquisition. Further details about
these agreements and other commitments and contingencies assumed with the Pharmion acquisition are
included in Note 14 to the accompanying consolidated financial statements.
Income Taxes Payable: We have provided a liability for unrecognized tax benefits related to
various federal, state and foreign income tax matters of $257.1 million at September 30, 2008. The
timing of the settlement of these amounts was not reasonably estimable at September 30, 2008. We
do not expect a settlement within the next 12 months.
40
Collaboration Arrangements: We have entered into certain research and development collaboration
arrangements with third parties that include the funding of certain development, manufacturing and
commercialization efforts with the potential for future milestone and royalty payments upon the
achievement of pre-established developmental, regulatory, and /or commercial targets. Our
obligation to fund these efforts is contingent upon continued involvement in the programs and/or
the lack of any adverse events which could cause the discontinuance of the programs.
Due to the nature of these arrangements, the future potential
payments are inherently uncertain, and accordingly no amounts have been recorded on our contractual obligations table.
Critical Accounting Estimates and Significant Accounting Policies
A critical accounting policy is one that is both important to the portrayal of our financial
condition and results of operation and requires managements most difficult, subjective or complex
judgments, often as a result of the need to make estimates about the effect of matters that are
inherently uncertain. Our significant accounting policies are more fully described in Note 1 of
the Notes to the Consolidated Financial Statements included in our Annual Report on Form 10-K for
the year ended December 31, 2007. Our critical accounting policies are disclosed in the
Managements Discussion and Analysis of Financial Condition and Results of Operations section of
our Annual Report on Form 10-K for the year ended December 31, 2007.
In addition to the critical accounting policies referenced above, the following are also
applicable:
Valuation of acquired intangible assets and acquired in-process research and development: We have
acquired intangible assets primarily through business combinations. When identifiable intangible
assets, including in-process research and development, are acquired we determine the fair values of
these assets as of the acquisition date. Discounted cash flow models are typically used in these
valuations, and the models require the use of significant estimates and assumptions including but
not limited to:
|
|
|
projecting regulatory approvals, |
|
|
|
estimating future cash flows from product sales resulting from completed products and
in-process projects and |
|
|
|
developing appropriate discount rates and probability rates by project. |
Derivatives and Hedging Activities: SFAS No. 133, Accounting for Derivative Instruments and
Hedging Activities, or SFAS 133, as amended, requires that all derivative instruments be
recognized on the balance sheet at their fair value. Changes in the fair value of derivative
instruments are recorded each period in current earnings or other comprehensive income (loss),
depending on whether a derivative instrument is designated as part of a hedging transaction and, if
it is, the type of hedging transaction. For a derivative to qualify as a hedge at inception and
throughout the hedged period, we formally document the nature and relationships between the hedging
instruments and hedged item. We assess, both at inception and on an on-going basis, whether the
derivative instruments that are used in cash flow hedging transactions are highly effective in
offsetting the changes in cash flows of hedged items. We assess hedge ineffectiveness on a
quarterly basis and record the gain or loss related to the ineffective portion of derivative
instruments, if any, to current earnings. If we determine that a forecasted transaction is no
longer probable of occurring, we discontinue hedge accounting and any related unrealized gain or
loss on the derivative instrument is recognized in current earnings. We use derivative
instruments, including those not designated as part of a hedging transaction, to manage our
exposure to movements in foreign exchange rates. The use of these derivative instruments modifies
the exposure of these risks with the intent to reduce our risk or cost. We do not use derivative
instruments for speculative trading purposes and are not a party to leveraged derivatives.
41
Item 3. Quantitative and Qualitative Disclosures about Market Risk
The following discussion provides forward-looking quantitative and qualitative information about
our potential exposure to market risk. Market risk represents the potential loss arising from
adverse changes in the value of financial instruments. The risk of loss is assessed based on the
likelihood of adverse changes in fair values, cash flows or future earnings.
We have established guidelines relative to the diversification and maturities of investments to
maintain safety and liquidity. These guidelines are reviewed periodically and may be modified
depending on market conditions. Although investments may be subject to credit risk, our investment
policy specifies credit quality standards for our investments and limits the amount of credit
exposure from any single issue, issuer or type of investment. At September 30, 2008, our market
risk sensitive instruments consisted of marketable securities available for sale, our note payable
and certain foreign currency forward contracts.
Marketable Securities Available for Sale: At September 30, 2008, our marketable securities
available for sale consisted of mortgage-backed obligations, U.S. Treasury securities, U.S.
government-sponsored agency securities, corporate debt securities and private cash fund shares.
Mortgage-backed obligations include fixed rate asset-backed securities issued by Fannie Mae,
Freddie Mac and the Government National Mortgage Association. U.S. government-sponsored agency
securities include general unsecured obligations of the issuing agency, including issues from the
Federal Home Loan Bank, Fannie Mae, and Freddie Mac. All three of these agencies are regulated by
the recently established FHFA. On September 7, 2008, the U.S. government, through the FHFA and the
U.S. Treasury, announced that it was placing both Fannie Mae and Freddie Mac into conservatorship,
with the FHFA assuming their day-to-day operations. On that same day, the U.S. Treasury
established a new secured lending credit facility available to Fannie Mae and Freddie Mac, which is
intended to serve as an ultimate liquidity backstop. This action, in essence, implemented the
temporary liquidity backstop authority granted to the U.S. Treasury by Congress in July 2008, and
will be available until December 2009. These measures were taken with the goal of preserving the
value of the debt and mortgage-backed securities issued by these U.S. government-sponsored agencies
as well as to ensure that these agencies have future access to capital. Celgene has not recorded
any impairments against its
holdings in these securities. Marketable securities available for sale are carried at fair value,
held for an unspecified period of time and intended for use in meeting our ongoing liquidity needs.
Unrealized gains and losses on available-for-sale securities, which are deemed to be temporary,
are reported as a separate component of stockholders equity, net of tax. The cost of debt
securities is adjusted for amortization of premiums and accretion of discounts to maturity. The
amortization, along with realized gains and losses and other than temporary impairment charges, is
included in interest and investment income, net.
As of September 30, 2008, the principal amounts, fair values and related weighted average interest
rates of our investments in debt securities classified as marketable securities available for sale
were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Duration |
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
|
More Than |
|
|
|
|
(Amounts in thousands) |
|
1 Year |
|
|
1 to 3 Years |
|
|
3 to 5 Years |
|
|
5 Years |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
$ |
363,351 |
|
|
$ |
465,340 |
|
|
$ |
74,980 |
|
|
$ |
20,000 |
|
|
$ |
923,671 |
|
Fair value |
|
$ |
365,813 |
|
|
$ |
472,681 |
|
|
$ |
77,463 |
|
|
$ |
20,432 |
|
|
$ |
936,389 |
|
Average interest rate |
|
|
3.3 |
% |
|
|
3.7 |
% |
|
|
3.1 |
% |
|
|
5.2 |
% |
|
|
3.5 |
% |
42
Note Payable: In December 2006, we purchased an active pharmaceutical ingredient, or API,
manufacturing facility and certain other assets and liabilities from Siegfried Ltd. and Siegfried
Dienste AG (together referred to herein as Siegfried) located in Zofingen, Switzerland. At
September 30, 2008, the fair value of our note payable to Siegfried approximated the carrying value
of the note of $24.2 million. Assuming other factors are held constant, an increase in interest
rates generally will result in a decrease in the fair value of the note. The note is denominated
in Swiss francs and its fair value will also be affected by changes in the U.S. dollar / Swiss
franc exchange rate. The carrying value of the note reflects the U.S. dollar / Swiss franc
exchange rate and Swiss interest rates.
Foreign Currency Forward Contracts: We use foreign currency forward contracts to hedge specific
forecasted intercompany transactions denominated in foreign currencies and to reduce exposures to
foreign currency fluctuations of certain assets and liabilities denominated in foreign currencies.
We enter into foreign currency forward contracts to protect against possible changes in values of
certain anticipated foreign currency cash flows resulting from changes in foreign currency exchange
rates, primarily associated with U.S. dollar denominated expenses incurred by subsidiaries in
Europe. These foreign currency forward contracts are designated as cash flow hedges and
accordingly, to the extent effective, any unrealized gains or losses on them are reported in other
comprehensive income (loss) and reclassified to earnings in the same periods during which the
underlying hedged transactions affect earnings. Any ineffectiveness on these foreign currency
forward contracts is reported in other income (expense), net. The foreign currency forward hedging
contracts outstanding at September 30, 2008 had an aggregate notional amount of approximately $75.7
million and had settlement dates within twelve months. The fair value of these contracts was $8.4
million and was included in other current assets at September 30, 2008, including gains, net of
tax, of $6.8 million included in other comprehensive income (loss).
We also enter into foreign currency forward contracts to reduce exposures to foreign currency
fluctuations of certain assets and liabilities denominated in foreign currencies. At September 30,
2008, we had foreign currency forward contracts outstanding denominated in various currencies,
including Euros, Swiss Francs, British Pounds, Japanese Yen and U.S. Dollars, with an aggregate
notional amount of approximately $366.9 million and expiring within twelve months. The foreign
currency forward contracts are economic hedges of
certain assets and liabilities that are remeasured through earnings each period along with the underlying
hedged item. At September 30, 2008, the fair value of these foreign currency forward contracts was
$11.7 million and was included in accrued expenses.
Although not predictive in nature, we believe a hypothetical 10% threshold reflects a reasonably
possible near-term change in foreign currency rates. Assuming that the September 30, 2008 exchange
rates were to change by a hypothetical 10% change in the underlying currencies, the fair value of
the foreign currency forward contracts would change by approximately
$28.7 million. Approximately $18.9 million of this
hypothetical change relates to foreign currency forward contracts
settled during the first week of October, which had an actual change
in fair value from September 30, 2008 that was not significant. However, since
the contracts either hedge specific forecasted intercompany transactions denominated in foreign
currencies or hedge assets and liabilities denominated in currencies other than the entities
functional currencies, any change in the fair value of the contract would be either reported in
other comprehensive income (loss) and reclassified to earnings in the same periods during which the
underlying hedged transactions affect earnings or remeasured through earnings each period along
with the underlying hedged item.
43
Item 4. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures. As of the end of the period covered by this
quarterly report, we carried out an evaluation, under the supervision and with the participation of
our management, including our Chief Executive Officer and Chief Financial Officer, of the
effectiveness of the design and operation of our disclosure controls and procedures (as defined in
the Securities Exchange Act of 1934 Rules 13a-15(e) and 15d-15(e)), or the Exchange Act. Based
upon the foregoing evaluation, our Chief Executive Officer and Chief Financial Officer have
concluded that our disclosure controls and procedures are effective to ensure that information
required to be disclosed by us in the reports that we file or submit under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified in the rules and
forms of the Securities and Exchange Commission.
(b) Changes in Internal Control over Financial Reporting. On March 7, 2008, we acquired Pharmion
Corporation. Until the accounting processes for former Pharmion entities are fully integrated, we
will continue to rely on previously established accounting processes and internal controls of
Pharmion. In all other instances, there have not been any other changes in our internal control
over financial reporting during the fiscal quarter to which this report relates that have
materially affected, or are reasonably likely to materially affect, our internal control over
financial report
PART II OTHER INFORMATION
Item 1. Legal Proceedings
Our legal proceedings are described in Part I, Item 3, Legal Proceedings, of our Annual Report on
Form 10-K for the year ended December 31, 2007, or our 2007 Annual Report on Form 10-K. There have
not been any material changes as it pertains to such legal proceedings nor have we engaged in any
additional material legal proceedings.
Item 1A. Risk Factors
The risk factors included in our 2007 Annual Report on Form 10-K have not materially changed,
except for the risks associated with our Pharmion acquisition consummated on March 7, 2008,
as described in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2008.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
44
Item 6. Exhibits
|
|
|
|
|
|
31.1 |
|
|
Certification by the Companys Chief Executive Officer. |
|
|
|
|
|
|
31.2 |
|
|
Certification by the Companys Chief Financial Officer. |
|
|
|
|
|
|
32.1 |
|
|
Certification by the Companys Chief Executive Officer pursuant to 18 U.S.C. Section 1350. |
|
|
|
|
|
|
32.2 |
|
|
Certification by the Companys Chief Financial Officer pursuant to 18 U.S.C. Section 1350. |
|
|
|
|
|
|
99.1 |
|
|
Termination of VIDAZA® License Agreement. |
45
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
CELGENE CORPORATION
|
|
DATE: October 29, 2008 |
By: |
/s/ David W. Gryska
|
|
|
|
David W. Gryska |
|
|
|
Sr. Vice President and
Chief Financial Officer |
|
|
|
|
DATE: October 29, 2008 |
By: |
/s/ Andre Van Hoek
|
|
|
|
Andre Van Hoek |
|
|
|
Controller and
Chief Accounting Officer |
|
46
Exhibit Index
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
|
|
31.1 |
|
|
Certification by the Companys Chief Executive Officer. |
|
|
|
|
|
|
31.2 |
|
|
Certification by the Companys Chief Financial Officer. |
|
|
|
|
|
|
32.1 |
|
|
Certification by the Companys Chief Executive Officer pursuant to 18 U.S.C. Section 1350. |
|
|
|
|
|
|
32.2 |
|
|
Certification by the Companys Chief Financial Officer pursuant to 18 U.S.C. Section 1350. |
|
|
|
|
|
|
99.1 |
|
|
Termination of VIDAZA® License Agreement. |